K091336 is an FDA 510(k) clearance for the IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Enthermics Medical Systems, Inc. (Washington, US). The FDA issued a Cleared decision on May 7, 2010, 366 days after receiving the submission on May 6, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K091336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2009 |
| Decision Date | May 07, 2010 |
| Days to Decision | 366 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LGZ — Warmer, Thermal, Infusion Fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |