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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K120412
Device Name 3M SPOTON TEMPERATURE MONITORING SYSTEM
Applicant
Arizant Healthcare, Inc.
10393 W. 70th St.
Eden Prairie,  MN  55344
Applicant Contact DAVID WESTLIN
Correspondent
Arizant Healthcare, Inc.
10393 W. 70th St.
Eden Prairie,  MN  55344
Correspondent Contact DAVID WESTLIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/10/2012
Decision Date 05/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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