The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Smartwire(tm)/flomap(r).
| Device ID | K925524 |
| 510k Number | K925524 |
| Device Name: | CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Michael J Billig |
| Correspondent | Michael J Billig CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1993-08-23 |