ThermAffyx(TM) Patient Safety System
Device Facts
| Record ID | K260278 |
|---|---|
| Device Name | ThermAffyx(TM) Patient Safety System |
| Applicant | Stihler Electronic GmbH |
| Product Code | DWJ · Cardiovascular |
| Decision Date | Jul 8, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.
