The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Flowire And Flomap.
Device ID | K905411 |
510k Number | K905411 |
Device Name: | FLOWIRE AND FLOMAP |
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 | 1990-12-03 |
Decision Date | 1991-03-29 |