FDA 510(k) Application Details - K211776

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K211776
Device Name Thermometer, Electronic, Clinical
Applicant Microlife Intellectual Property GmbH
Espenstrasse 139
Widnau 9443 CH
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Contact Gerhard Frick
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 06/09/2021
Decision Date 03/01/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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