The following data is part of a premarket notification filed by Medis Medical Imaging Systems, Inc. with the FDA for Cardiovascular Measurement System-cms.
| Device ID | K940172 |
| 510k Number | K940172 |
| Device Name: | CARDIOVASCULAR MEASUREMENT SYSTEM-CMS |
| Classification | System, X-ray, Angiographic |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, INC. 109 DANBURY RD. Ridgefield, CT 06877 |
| Contact | Douglas Orr |
| Correspondent | Douglas Orr MEDIS MEDICAL IMAGING SYSTEMS, INC. 109 DANBURY RD. Ridgefield, CT 06877 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-11 |
| Decision Date | 1994-09-29 |