The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Biplane Transrectal Probe.
| Device ID | K914006 |
| 510k Number | K914006 |
| Device Name: | BIPLANE TRANSRECTAL PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | William E Mckay |
| Correspondent | William E Mckay BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 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 | 1991-09-09 |
| Decision Date | 1992-04-02 |