The following data is part of a premarket notification filed by Diasonics Ultrasound with the FDA for Diasonics Masters Series 5000 Ultrasound Scanner.
| Device ID | K951998 |
| 510k Number | K951998 |
| Device Name: | DIASONICS MASTERS SERIES 5000 ULTRASOUND SCANNER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | DIASONICS ULTRASOUND 2860 DELA CRUZ BLVD. Santa Clara, CA 95050 |
| Contact | Gregory S Lin |
| Correspondent | Gregory S Lin DIASONICS ULTRASOUND 2860 DELA CRUZ BLVD. Santa Clara, CA 95050 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-28 |
| Decision Date | 1996-03-27 |