BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM


Device Classification Name

system, thermal regulating

510(k) Number K110104
Device Name BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
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

Correspodent Contact steven j berke
Regulation Number 870.5900
Classification Product Code
DWJ  
Date Received 01/13/2011
Decision Date 02/04/2011
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