K130867 is an FDA 510(k) clearance for the ENFLOW IV FLUID WARMER INSULATED STRAP. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Vital Signs, Inc., A GE Healthcare Company (Totowa, US). The FDA issued a Cleared decision on June 14, 2013, 78 days after receiving the submission on March 28, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K130867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2013 |
| Decision Date | June 14, 2013 |
| Days to Decision | 78 days |
| Submission Type | Special |
| 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 |