FORM FDA 3654 PSC Graphics

We use cookies to personalise content and ads, to provide social media features and to analyse traffic. We share info about use of our site with social media, ads and analytics partners. By continuing to browse you are agreeing to use of cookies. See details or close this message.

Page

100%

Specifications	FORM FDA 3654 PSC Graphics
Business section

Please answer the following questions Is this standard recognized by FDA 2 ? . FDA Recognition number 3 . Was a third party l

Specifications	FORM FDA 3654 PSC Graphics
Suggested Link Details/Purchase
Content	Please answer the following questions Is this standard recognized by FDA 2 ? . FDA Recognition number 3 . Was a third party laboratory responsible for testing conformity of the device to this standard identified in the 510(k)? . Is a summary report 4 describing the extent of conformance of the standard used included in the If no, complete a summary report table. Does the test data for this device demonstrate conformity to the requirements of this standard as it pertains to this device? . Does this standard include acceptance criteria? . Does this standard include more than one option or selection of tests? . Were there any deviations or adaptations made in the use of the standard?. Were deviations or adaptations made beyond what is specified in the FDA SIS?. If yes, report these deviations or adaptations in the summary report table. Were there any exclusions from the standard? . Is there an FDA guidance 6 that is associated with this standard?. If yes, was the guidance document followed in preparation of this 510k? . Title of guidance: 1The formatting convention for the title is: [SDO] [numeric identifier] [title of standard] [date of publication] 2Authority [21 U.S.C. 360d], http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Standards/default.htm 3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 4The summary report should include: any adaptations used to adapt to the device under review (for example, alternative test methods); choices made when options or a selection of methods are described; deviations from the standard; requirements not applicable to the device; and the name and address of the test laboratory or certification body involved in conformance assessment to this standard. The summary report includes information on all standards utilized during the development of the device. Department of Health and Human Services Food and Drug Administration STANDARDS DATA REPORT FOR 510(k)s (To be filled in by applicant) This report and the Summary Report Table are to be completed by the applicant when submitting a 510(k) that refer- ences a national or international standard. A separate report is required for each standard referenced in the 510(k). TYPE OF 510(K) SUBMISSION TraditionalSpecialAbbreviated STANDARD TITLE 1 YesNo # Form Approved: OMB No. 0910-0120; Expiration Date: 12/31/13 FORM FDA 3654 (6/11)Page 1PSC Publishing Services (301) 443-6740EF 510(k)? . If yes, were deviations in accordance with the FDA supplemental information sheet (SIS) 5 ? . If no, include the results of testing in the 510(k). If yes, report options selected in the summary report table. If yes, report these exclusions in the summary report table. The online search for CDRH Guidance Documents can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/default.htm 5The supplemental information sheet (SIS) is additional information which is necessary before FDA recognizes the standard. Found at http:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 6
Navigation	Previous Page / Next Page
Suggested Link Details/Purchase

Following Datasheets	UCM081671 (76 pages) UCM082348_1 (4 pages) UCM082359_1 (2 pages) UCM082725-1_1 (1 pages) UCM082725_1 (1 pages) UCM083533_1 (2 pages) UCM083558_1 (2 pages) UCM083570_1 (1 pages) ucm085819_1 (3 pages) UCM086233_1 (46 pages)
Check in e-portals	World-H-News Products Extensions Partners Automation Jet Parts
Sitemap Folder	group1 group2 group3 group4 group5 group6 group7 group8 group9 group10 group11 group12 group13 group14 group15 group16 group17 group18 group19 group20 group21 group22 group23 group24 group25 group26 group27 group28 group29 group30 group31 group32 group33 group34 group35 group36 group37 group38 group39 group40 group41 group42 group43 group44 group45 group46 group47 group48 group49 group50 group51 group52 group53 group54 group55 group56 group57 group58 group59 group60 group61 group62 group63 group64 group65 group66 group67 group68 group69 group70 group71 group72 group73 group74 group75 group76 group77 group78 group79 group80 group81 group82 group83 group84 group85 group86 group87 group88 group89 group90 group91 group92 group93 group94 group95 group96 group97 group98 group99 group100 Prewious Folder Next Folder