The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Cas 740 Series Monitor, Models 740-1, 740m-1, 740-2ms, 740m-2ms, 740-2nl, 740m-2nl, 740-2nn, 740m-2nn, 740-3ms, 740m-3ms.
| Device ID | K033048 |
| 510k Number | K033048 |
| Device Name: | CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-06-01 |
| Summary: | summary |