HEARTRAK
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.
Pre-market Notification Details
| Device ID | K943124 |
| 510k Number | K943124 |
| Device Name: | HEARTRAK |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | UNIVERSAL MEDICAL, INC. 1608 WALNUT ST. SIXTH FLOOR Philadelphia, PA 19103 |
| Contact | Brian M Fleischer |
| Correspondent | Brian M Fleischer UNIVERSAL MEDICAL, INC. 1608 WALNUT ST. SIXTH FLOOR Philadelphia, PA 19103 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1995-05-03 |
Trademark Results [HEARTRAK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARTRAK 74622698 1989324 Live/Registered |
Universal Medical, Inc. 1995-01-18 |
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