The following data is part of a premarket notification filed by Cincinnati Sub-zero Products, Inc with the FDA for Warm Air Model 135 Hyperthermia System And Blankets.
| Device ID | K101148 |
| 510k Number | K101148 |
| Device Name: | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS |
| Classification | System, Thermal Regulating |
| Applicant | CINCINNATI SUB-ZERO PRODUCTS, INC 12011 MOSTELLER ROAD Cincinnati, OH 45241 |
| Contact | Steven J Berke |
| Correspondent | Steven J Berke CINCINNATI SUB-ZERO PRODUCTS, INC 12011 MOSTELLER ROAD Cincinnati, OH 45241 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-23 |
| Decision Date | 2010-10-01 |
| Summary: | summary |