K161602 is an FDA 510(k) clearance for the Arctic Sun Temperature Management System. This device is classified as a System, Thermal Regulating (Class II - Special Controls, product code DWJ).
Submitted by Medivance, Inc. (Louisville, US). The FDA issued a Cleared decision on September 2, 2016, 85 days after receiving the submission on June 9, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5900. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K161602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2016 |
| Decision Date | September 02, 2016 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWJ - System, Thermal Regulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5900 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |