The following data is part of a premarket notification filed by Cincinnati Sub-zero Products, Inc. with the FDA for Blanketrol Iii, Model 233 And Coolblue, Model 25-01 Hyper-hypothermia Systems.
| Device ID | K101589 |
| 510k Number | K101589 |
| Device Name: | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS |
| Classification | System, Thermal Regulating |
| Applicant | CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. Cincinnati, OH 45241 |
| Contact | Steven J Berke |
| Correspondent | Steven J Berke CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. 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 | 2010-06-07 |
| Decision Date | 2010-09-20 |
| Summary: | summary |