K153162 is an FDA 510(k) clearance for the Hypocore. This device is classified as a System, Hypothermia, Intravenous, Cooling (Class II - Special Controls, product code NCX).
Submitted by Novocor Medical Systems, Inc. (Durham, US). The FDA issued a Cleared decision on May 24, 2016, 204 days after receiving the submission on November 2, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.5900.
| 510(k) Number | K153162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2015 |
| Decision Date | May 24, 2016 |
| Days to Decision | 204 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 |