The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Biopsy Accessory For Ultrasound Transducer.
| Device ID | K971700 |
| 510k Number | K971700 |
| Device Name: | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BIOSOUND, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Gerald A Richardson |
| Correspondent | Gerald A Richardson BIOSOUND, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-08 |
| Decision Date | 1997-07-09 |
| Summary: | summary |