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FDA 510(k) Application Details - K190073
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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