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 |