The following data is part of a premarket notification filed by Biosound, Inc. with the FDA for Ezu-pc 2a/5.0 & 3a/3.5mhz, Eup-cd 121/5.0 Convex.
| Device ID | K870899 |
| 510k Number | K870899 |
| Device Name: | EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 Indianapolis, IN 46250 |
| Contact | Robert Courtney |
| Correspondent | Robert Courtney 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 | 1987-03-05 |
| Decision Date | 1987-12-30 |