The following data is part of a premarket notification filed by Stryker Medical with the FDA for Altrix Precision Temperature Management System.
| Device ID | K180834 |
| 510k Number | K180834 |
| Device Name: | Altrix Precision Temperature Management System |
| Classification | System, Thermal Regulating |
| Applicant | Stryker Medical 3800 East Centre Avenue Portage, MI 49002 |
| Contact | Brian Orwat |
| Correspondent | Brian Orwat Stryker Medical 3800 East Centre Avenue Portage, MI 49002 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-08-10 |
| Summary: | summary |