The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Oscillomitt, Models Cm 1050, Cm 1040, Cm 1030, Cm 1020, Cm 1010.
| Device ID | K000512 |
| 510k Number | K000512 |
| Device Name: | OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 |
| Classification | Blood Pressure Cuff |
| 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 | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-16 |
| Decision Date | 2000-09-26 |