K180834 is an FDA 510(k) clearance for the Altrix Precision Temperature Management System. This device is classified as a System, Thermal Regulating (Class II - Special Controls, product code DWJ).
Submitted by Stryker Medical (Portage, US). The FDA issued a Cleared decision on August 10, 2018, 133 days after receiving the submission on March 30, 2018.
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 | K180834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2018 |
| Decision Date | August 10, 2018 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| 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). |