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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K101589
Device Name BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
Applicant
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 MOSTELLER RD.
CINCINNATI,  OH  45241
Applicant Contact STEVEN J BERKE
Correspondent
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 MOSTELLER RD.
CINCINNATI,  OH  45241
Correspondent Contact STEVEN J BERKE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/07/2010
Decision Date 09/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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