The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Biosound Phase 2 Diagnostic Ultrasound System.
| Device ID | K895645 |
| 510k Number | K895645 |
| Device Name: | BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | Steven L Hart |
| Correspondent | Steven L Hart BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1990-03-06 |