The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Oscillomate Nibp / Sp02 Ems Monitor.
| Device ID | K980879 |
| 510k Number | K980879 |
| Device Name: | OSCILLOMATE NIBP / SP02 EMS MONITOR |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-09 |
| Decision Date | 1998-07-16 |
| Summary: | summary |