K152946 is an FDA 510(k) clearance for the TEMPEDY. This device is classified as a System, Hypothermia, Intravenous, Cooling (Class II - Special Controls, product code NCX).
Submitted by Seiratherm GmbH (91074 Herzogenaurach, DE). The FDA issued a Cleared decision on September 15, 2016, 345 days after receiving the submission on October 6, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.5900.
| 510(k) Number | K152946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2015 |
| Decision Date | September 15, 2016 |
| Days to Decision | 345 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NCX — System, Hypothermia, Intravenous, Cooling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5900 |