The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Ultrasound Imagaing System And Doppler Flowmeter.
Device ID | K920678 |
510k Number | K920678 |
Device Name: | ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
Contact | Richard Derman |
Correspondent | Richard Derman INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-14 |
Decision Date | 1992-04-02 |