HEARTRAK SMART ECAT
Transmitters And Receivers, Electrocardiograph, Telephone
UNIVERSAL MEDICAL, INC.
The following data is part of a premarket notification filed by Universal Medical, Inc. with the FDA for Heartrak Smart Ecat.
Pre-market Notification Details
| Device ID | K083535 |
| 510k Number | K083535 |
| Device Name: | HEARTRAK SMART ECAT |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | UNIVERSAL MEDICAL, INC. 275 PHILLIPS BLVD. Ewing, NJ 08618 |
| Contact | Joyce W Dean |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-11-28 |
| Decision Date | 2008-12-15 |
| Summary: | summary |
Trademark Results [HEARTRAK SMART ECAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARTRAK SMART ECAT 77754391 not registered Dead/Abandoned |
Universal Medical, Inc. 2009-06-08 |
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