The following data is part of a premarket notification filed by Zoll Circulation with the FDA for Autopulse Resuscitation System Model 1000.
| Device ID | K112998 |
| 510k Number | K112998 |
| Device Name: | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 |
| Classification | Compressor, Cardiac, External |
| Applicant | ZOLL CIRCULATION 2000 Ringwood Ave San Jose, CA 95131 |
| Contact | Sam Nanavati |
| Correspondent | Sam Nanavati ZOLL CIRCULATION 2000 Ringwood Ave San Jose, CA 95131 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-07 |
| Decision Date | 2012-03-15 |
| Summary: | summary |