The following data is part of a premarket notification filed by Stryker Medical with the FDA for Altrix Precision Temperature Management System.
| Device ID | K152266 |
| 510k Number | K152266 |
| 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 | 2015-08-11 |
| Decision Date | 2016-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327374186 | K152266 | 000 |
| 07613327175301 | K152266 | 000 |
| 07613327175325 | K152266 | 000 |
| 07613327175349 | K152266 | 000 |
| 07613327175363 | K152266 | 000 |
| 07613327175394 | K152266 | 000 |
| 07613327175400 | K152266 | 000 |
| 57613327261344 | K152266 | 000 |
| 57613327261382 | K152266 | 000 |
| 57613327261399 | K152266 | 000 |
| 57613327261405 | K152266 | 000 |
| 07613327277555 | K152266 | 000 |
| 07613327369014 | K152266 | 000 |
| 07613327175295 | K152266 | 000 |