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 |