BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM

System, Thermal Regulating

CINCINNATI SUB-ZERO PRODUCTS, INC.

The following data is part of a premarket notification filed by Cincinnati Sub-zero Products, Inc. with the FDA for Blanketrol Ii Hyper-hypothermia Temperature Managment System.

Pre-market Notification Details

Device IDK110104
510k NumberK110104
Device Name:BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
ClassificationSystem, Thermal Regulating
Applicant CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. Cincinnati,  OH  45241
ContactSteven J Berke
CorrespondentSteven J Berke
CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. Cincinnati,  OH  45241
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-13
Decision Date2011-02-04
Summary:summary

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