The following data is part of a premarket notification filed by Revivant Corp. with the FDA for Autopulse, Model 100.
| Device ID | K011046 |
| 510k Number | K011046 |
| Device Name: | AUTOPULSE, MODEL 100 |
| Classification | Compressor, Cardiac, External |
| Applicant | REVIVANT CORP. 775 PALOMAR Sunnyvale, CA 94085 |
| Contact | Bob Katz |
| Correspondent | Bob Katz REVIVANT CORP. 775 PALOMAR Sunnyvale, CA 94085 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-06 |
| Decision Date | 2001-10-25 |