K953741 is an FDA 510(k) clearance for the THERMACYL BLOOD/FLUID WARMER. This device is classified as a Warmer, Blood, Non-electromagnetic Radiation (Class II - Special Controls, product code BSB).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on June 26, 1996, 321 days after receiving the submission on August 10, 1995.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9205.
| 510(k) Number | K953741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1995 |
| Decision Date | June 26, 1996 |
| Days to Decision | 321 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | BSB — Warmer, Blood, Non-electromagnetic Radiation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9205 |