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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 K152748
Device Name Braun Thermoscan PRO 6000 Ear Thermometer
Applicant
Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
250 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact RAJ KASBEKAR
Correspondent
Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)
250 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact RAJ KASBEKAR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/23/2015
Decision Date 03/01/2016
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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