K153713 is an FDA 510(k) clearance for the Getinge Series Warming Cabinet. This device is classified as a Warmer, Irrigation Solution (Class I — General Controls, product code LHC).
Submitted by Getinge Sourcing, LLC (Rochester, US). The FDA issued a Cleared decision on June 7, 2016, 166 days after receiving the submission on December 24, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 890.5950.
| 510(k) Number | K153713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2015 |
| Decision Date | June 07, 2016 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHC — Warmer, Irrigation Solution |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5950 |