K090736 is an FDA 510(k) clearance for the POWER INFUSER, MODEL M100B-3A. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on May 20, 2009, 62 days after receiving the submission on March 19, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K090736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2009 |
| Decision Date | May 20, 2009 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |