The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Modification To Model 750 Series Monitor.
| Device ID | K063087 |
| 510k Number | K063087 |
| Device Name: | MODIFICATION TO MODEL 750 SERIES MONITOR |
| Classification | Monitor, Physiological, Patient (without 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 | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2006-12-11 |
| Summary: | summary |