The following data is part of a premarket notification filed by Teknar, Inc. with the FDA for B-scan 10 Mhz Probe.
| Device ID | K896038 |
| 510k Number | K896038 |
| Device Name: | B-SCAN 10 MHZ PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TEKNAR, INC. 267 WOLFNER DR. Fenton, MO 63026 -2801 |
| Contact | Kenneth O Head |
| Correspondent | Kenneth O Head TEKNAR, INC. 267 WOLFNER DR. Fenton, MO 63026 -2801 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-16 |
| Decision Date | 1990-04-23 |