The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Vasoview Duplex Imaging System.
| Device ID | K861237 |
| 510k Number | K861237 |
| Device Name: | VASOVIEW DUPLEX IMAGING SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SONICAID, INC. P.O. BOX 588 Fredericksburg, VA 22401 |
| Contact | Robert D Washam |
| Correspondent | Robert D Washam SONICAID, INC. P.O. BOX 588 Fredericksburg, VA 22401 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-02 |
| Decision Date | 1986-07-14 |