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 |