The following data is part of a premarket notification filed by Medcool Inc with the FDA for Rapidcool Patient Temperature Management System.
| Device ID | K070112 |
| 510k Number | K070112 |
| Device Name: | RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM |
| Classification | System, Thermal Regulating |
| Applicant | MEDCOOL INC 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell MEDCOOL INC 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-11 |
| Decision Date | 2007-07-13 |
| Summary: | summary |