The following data is part of a premarket notification filed by Revivant Corp. with the FDA for Autopulse Resuscitation System.
Device ID | K022345 |
510k Number | K022345 |
Device Name: | AUTOPULSE RESUSCITATION SYSTEM |
Classification | Compressor, Cardiac, External |
Applicant | REVIVANT CORP. 775 PALOMAR AVE. Sunnyvale, CA 94085 |
Contact | Susanne T Smith |
Correspondent | Susanne T Smith REVIVANT CORP. 775 PALOMAR AVE. Sunnyvale, CA 94085 |
Product Code | DRM |
CFR Regulation Number | 870.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-19 |
Decision Date | 2002-08-15 |
Summary: | summary |