The following data is part of a premarket notification filed by Diasonics Ultrasound with the FDA for Diasonics Itnraoperative Probes.
| Device ID | K961002 |
| 510k Number | K961002 |
| Device Name: | DIASONICS ITNRAOPERATIVE PROBES |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | DIASONICS ULTRASOUND 2860 DELA CRUZ BLVD. Santa Clara, CA 95050 |
| Contact | Jerry W Tsutsumi |
| Correspondent | Jerry W Tsutsumi DIASONICS ULTRASOUND 2860 DELA CRUZ BLVD. Santa Clara, CA 95050 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-12 |
| Decision Date | 1997-01-22 |