PACETRAK PLUS
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 Pacetrak Plus.
Pre-market Notification Details
| Device ID | K954495 |
| 510k Number | K954495 |
| Device Name: | PACETRAK PLUS |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | UNIVERSAL MEDICAL, INC. 1760 MARKET ST. 13TH FLOOR Philadelphia, PA 19103 |
| Contact | Douglas M Lurio |
| Correspondent | Douglas M 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 | 1995-09-27 |
| Decision Date | 1996-04-22 |
Trademark Results [PACETRAK PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PACETRAK PLUS 75001672 2074442 Dead/Cancelled |
Universal Medical, Inc. 1995-10-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.