The following data is part of a premarket notification filed by Physiowave, Inc. with the FDA for Cardiovascular Analzyer.
Device ID | K172431 |
510k Number | K172431 |
Device Name: | Cardiovascular Analzyer |
Classification | Plethysmograph, Impedance |
Applicant | PhysioWave, Inc. 1700 Wyatt Drive Suite 2 Santa Clara, CA 95054 |
Contact | Laurent Giovangrandi |
Correspondent | Diana Degregorio Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, CA 94583 |
Product Code | DSB |
Subsequent Product Code | DSK |
Subsequent Product Code | DXN |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-11 |
Decision Date | 2018-03-14 |
Summary: | summary |