The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Oscillomate Non-invasive Blood Pressure Monitor.
| Device ID | K972020 |
| 510k Number | K972020 |
| Device Name: | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR |
| Classification | System, Phonocatheter, Intracavitary |
| Applicant | CAS MEDICAL SYSTEMS, INC. 21 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Ron Jeffrey |
| Correspondent | Ron Jeffrey CAS MEDICAL SYSTEMS, INC. 21 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | DXW |
| CFR Regulation Number | 870.1270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1998-05-05 |
| Summary: | summary |