The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Vingmed Sound Color Flow Mapping System.
| Device ID | K962662 |
| 510k Number | K962662 |
| Device Name: | VINGMED SOUND COLOR FLOW MAPPING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DIASONICS, INC. 1592 HARBOR RD. Williamsburg, VA 23185 |
| Contact | Walter E Gundaker |
| Correspondent | Walter E Gundaker DIASONICS, INC. 1592 HARBOR RD. Williamsburg, VA 23185 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1997-01-02 |
| Summary: | summary |