CARDEASCREEN
Electrocardiograph
CARDEA ASSOCIATES INC
The following data is part of a premarket notification filed by Cardea Associates Inc with the FDA for Cardeascreen.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857553006009 | K123217 | 000 |
| 00857553006016 | K123217 | 000 |
Trademark Results [CARDEASCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDEASCREEN 85335302 4335458 Dead/Cancelled |
Cardea Associates, Inc. 2011-06-01 |
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