The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Flowire/flomap System.
| Device ID | K921563 |
| 510k Number | K921563 |
| Device Name: | CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Michael Billig |
| Correspondent | Michael Billig CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-01 |
| Decision Date | 1992-07-01 |