K883873 is an FDA 510(k) clearance for the INFUSION FLUID WARMER. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on February 28, 1989, 168 days after receiving the submission on September 13, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K883873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1988 |
| Decision Date | February 28, 1989 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LGZ — Warmer, Thermal, Infusion Fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |