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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 K211776
Device Name Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
Applicant
Microlife Intellectual Property GmbH
Espenstrasse 139
Widnau,  CH 9443
Applicant Contact Gerhard Frick
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Arvind Rajal
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/09/2021
Decision Date 03/01/2022
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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