The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Oscillomate (tm) Blood Pressure Monitor-model 1630.
| Device ID | K911722 |
| 510k Number | K911722 |
| Device Name: | OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Edward W Jackson |
| Correspondent | Edward W Jackson CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-17 |
| Decision Date | 1992-01-22 |