K012832 is an FDA 510(k) clearance for the COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on October 24, 2001, 62 days after receiving the submission on August 23, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K012832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2001 |
| Decision Date | October 24, 2001 |
| Days to Decision | 62 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 |