The following data is part of a premarket notification filed by American Healthcare Products, Inc. with the FDA for Prn Thermalcare, Model 3000.
| Device ID | K062794 |
| 510k Number | K062794 |
| Device Name: | PRN THERMALCARE, MODEL 3000 |
| Classification | System, Thermal Regulating |
| Applicant | AMERICAN HEALTHCARE PRODUCTS, INC. 3220 S. HANFORD STREET Seattle, WA 98144 |
| Contact | Kent D Ellis |
| Correspondent | Kent D Ellis AMERICAN HEALTHCARE PRODUCTS, INC. 3220 S. HANFORD STREET Seattle, WA 98144 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2006-12-07 |
| Summary: | summary |