FDA 510(k) Application Details - K190073

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K190073
Device Name System,Network And Communication,Physiological Monitors
Applicant Current Health Ltd
Playfair House, 12A Broughton Street Lane
Edinburgh EH1 3LY GB
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Contact Edwin Lindsay
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 01/16/2019
Decision Date 03/27/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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