The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Oscillomate Neonatal Blood Press. Monit.-model 901.
| Device ID | K860196 |
| 510k Number | K860196 |
| Device Name: | OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Cohen, Ph.d |
| Correspondent | Cohen, Ph.d 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 | 1986-01-22 |
| Decision Date | 1986-05-12 |