K112998 is an FDA 510(k) clearance for the AUTOPULSE RESUSCITATION SYSTEM MODEL 1000. This device is classified as a Compressor, Cardiac, External (Class II - Special Controls, product code DRM).
Submitted by Zoll Circulation (San Jose, US). The FDA issued a Cleared decision on March 15, 2012, 160 days after receiving the submission on October 7, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5200.
| 510(k) Number | K112998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2011 |
| Decision Date | March 15, 2012 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRM — Compressor, Cardiac, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5200 |