The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Arctic Sun Temperature Management System, Model 100 Control Unit And Patient Energy Transfer Pads.
| Device ID | K002577 |
| 510k Number | K002577 |
| Device Name: | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS |
| Classification | System, Thermal Regulating |
| Applicant | MEDIVANCE, INC. 500 S. ARTHUR AVENUE, STE 100 Louisville, CO 80027 |
| Contact | Robert A Kline |
| Correspondent | Robert A Kline MEDIVANCE, INC. 500 S. ARTHUR AVENUE, STE 100 Louisville, CO 80027 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-18 |
| Decision Date | 2000-10-26 |