Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Correspondent Contact STEVEN J BERKE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received01/13/2011
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
-
-