K052055 is an FDA 510(k) clearance for the SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200. This device is classified as a Warmer, Thermal, Infusion Fluid (Class II - Special Controls, product code LGZ).
Submitted by Smisson-Cartledge Biomedical, LLC (Alpharetta, US). The FDA issued a Cleared decision on October 26, 2006, 454 days after receiving the submission on July 29, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K052055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2005 |
| Decision Date | October 26, 2006 |
| Days to Decision | 454 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 |