The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Flowire & Flomap.
Device ID | K932536 |
510k Number | K932536 |
Device Name: | CARDIOMETRICS FLOWIRE & FLOMAP |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
Contact | Susan Osborne |
Correspondent | Susan Osborne 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 | 1993-05-26 |
Decision Date | 1993-09-28 |