The following data is part of a premarket notification filed by Cincinnati Sub-zero Products, Inc. with the FDA for Norm-o-temp Hyperthermia System Incliding Blankets/pads.
| Device ID | K120081 |
| 510k Number | K120081 |
| Device Name: | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS |
| 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 | 2012-01-11 |
| Decision Date | 2012-02-17 |
| Summary: | summary |