The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Linear Peripheralvascular Ultrsound Probe.
| Device ID | K915860 |
| 510k Number | K915860 |
| Device Name: | LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BIOSOUND, INC. 6110 BOLLINGER RD. San Jose, CA 95129 |
| Contact | William E Mckay |
| Correspondent | William E Mckay BIOSOUND, INC. 6110 BOLLINGER RD. San Jose, CA 95129 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1992-07-02 |