Submission Details
| 510(k) Number | K992258 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 06, 1999 |
| Decision Date | January 12, 2000 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
K992258 is an FDA 510(k) clearance for the HOT SHOT FLUID WARMER IV FLUIDS, submitted by Infra-Med Technologies, Inc. (Flower Mound, US). The FDA issued a Cleared decision on January 12, 2000, 190 days after receiving the submission on July 6, 1999. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K992258 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 06, 1999 |
| Decision Date | January 12, 2000 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | LDQ |
| Device Class | — |