The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Cw Doppler 2.25 Mhz Probe.
Device ID | K903562 |
510k Number | K903562 |
Device Name: | CW DOPPLER 2.25 MHZ PROBE |
Classification | Transducer, Ultrasonic, Diagnostic |
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 | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-07 |
Decision Date | 1992-03-02 |