HEARTRAK XL
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 Xl.
Pre-market Notification Details
| Device ID | K960499 |
| 510k Number | K960499 |
| Device Name: | HEARTRAK XL |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | UNIVERSAL MEDICAL, INC. 1760 MARKET ST. 13TH FLOOR Philadelphia, PA 19103 |
| Contact | Margaret S Lurio |
| Correspondent | Margaret S Lurio UNIVERSAL MEDICAL, INC. 1760 MARKET ST. 13TH 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 | 1996-02-02 |
| Decision Date | 1996-08-06 |
Trademark Results [HEARTRAK XL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARTRAK XL 75109148 2136241 Dead/Cancelled |
Universal Medical, Inc. 1996-05-24 |
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