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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 K132514
Device Name KINSA SMART THERMOMETER
Applicant
Kinsa, Inc.
603 Greenwich St. #101b
New York,  NY  10014
Applicant Contact LAEL J PICKETT
Correspondent
Kinsa, Inc.
603 Greenwich St. #101b
New York,  NY  10014
Correspondent Contact LAEL J PICKETT
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/12/2013
Decision Date 12/02/2013
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
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