The following data is part of a premarket notification filed by Cardea Associates Inc with the FDA for Cardeascreen.
Device ID | K123217 |
510k Number | K123217 |
Device Name: | CARDEASCREEN |
Classification | Electrocardiograph |
Applicant | CARDEA ASSOCIATES INC 137220 220TH PLACE NE Woodinville, WA 98077 |
Contact | David M Hadley |
Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-10-15 |
Decision Date | 2013-02-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857553006009 | K123217 | 000 |
00857553006016 | K123217 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CARDEASCREEN 85335302 4335458 Dead/Cancelled |
Cardea Associates, Inc. 2011-06-01 |