The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Oscillomate Ems Nibp Monitor Model 9001.
| Device ID | K982135 |
| 510k Number | K982135 |
| Device Name: | OSCILLOMATE EMS NIBP MONITOR MODEL 9001 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1998-09-15 |