The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Press-mate Advantage.
| Device ID | K973637 |
| 510k Number | K973637 |
| Device Name: | PRESS-MATE ADVANTAGE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio, TX 78249 |
| Contact | Mark Rison |
| Correspondent | Mark Rison COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio, TX 78249 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-24 |
| Decision Date | 1998-09-25 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRESS-MATE ADVANTAGE 75302346 2231204 Live/Registered |
FUKUDA DENSHI CO., LTD. 1997-06-03 |