ALLON 2001
Device Facts
| Record ID | K001546 |
|---|---|
| Device Name | ALLON 2001 |
| Applicant | Mtre Advanced Technology , Ltd. |
| Product Code | DWJ · Cardiovascular |
| Decision Date | Jun 8, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.