The following data is part of a premarket notification filed by Bruel & Kjaer Industri A/s with the FDA for Biopsy Fixation Unit-type Ua 0997.
| Device ID | K875357 |
| 510k Number | K875357 |
| Device Name: | BIOPSY FIXATION UNIT-TYPE UA 0997 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BRUEL & KJAER INDUSTRI A/S 18 NAERUM HOVEDGADE DK-2850 NAERUM Denmark, DK |
| Contact | Aage Ruby |
| Correspondent | Aage Ruby BRUEL & KJAER INDUSTRI A/S 18 NAERUM HOVEDGADE DK-2850 NAERUM Denmark, DK |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-31 |
| Decision Date | 1988-07-01 |