The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for 750c Series Monitor, Models 750c-2ms, 750cm-2ms, 750c-nnl, 750cm-2nl, 750c-3ms, 750cm-3ms, 750c-3nl, 750cm-3nl.
| Device ID | K050844 |
| 510k Number | K050844 |
| Device Name: | 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL |
| Classification | Oximeter |
| Applicant | CAS MEDICAL SYSTEMS, INC. 44 EAST INDUSTRIAL RD. Branford, CT 06405 |
| Contact | Ron Jeffrey |
| Correspondent | Ron Jeffrey CAS MEDICAL SYSTEMS, INC. 44 EAST INDUSTRIAL RD. 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 | 2005-04-04 |
| Decision Date | 2005-06-23 |
| Summary: | summary |