The following data is part of a premarket notification filed by Medis Medical Imaging Systems, B.v. with the FDA for Cardiovascular Measurement System - View.
| Device ID | K993761 |
| 510k Number | K993761 |
| Device Name: | CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDIS MEDICAL IMAGING SYSTEMS, B.V. 109 DANBURY RD. Ridgefield, CT 06877 |
| Contact | Douglas F Orr |
| Correspondent | Douglas F Orr MEDIS MEDICAL IMAGING SYSTEMS, B.V. 109 DANBURY RD. Ridgefield, CT 06877 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-08 |
| Decision Date | 1999-12-28 |
| Summary: | summary |