The following data is part of a premarket notification filed by Universal Medical, Inc. with the FDA for Cardiostation.
| Device ID | K980624 |
| 510k Number | K980624 |
| Device Name: | CARDIOSTATION |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | UNIVERSAL MEDICAL, INC. 1608 WALNUT ST. SIXTH FLOOR Philadelphia, PA 19103 |
| Contact | Douglas M Lurio |
| Correspondent | Douglas M Lurio 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 | 1998-02-18 |
| Decision Date | 1998-05-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CARDIOSTATION 76576867 2930373 Live/Registered |
Universal Medical, Inc. 2004-02-20 |
![]() CARDIOSTATION 74675158 not registered Dead/Abandoned |
Mennen Medical, Ltd. 1995-05-16 |