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 |