The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Spectra Ultrasound System W/color Flow Module.
| Device ID | K891452 |
| 510k Number | K891452 |
| Device Name: | SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Contact | Charles A Kanter |
| Correspondent | Charles A Kanter DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-15 |
| Decision Date | 1989-06-07 |