The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Flomap And Flomod Ultrasound Instrument.
| Device ID | K933320 |
| 510k Number | K933320 |
| Device Name: | CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Susan E Osborne |
| Correspondent | Susan E Osborne CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-07 |
| Decision Date | 1994-08-17 |