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FDA 510(k) Application Details - K201635
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K201635
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
MultiSensor Diagnostics (dba Aidar Health)
3402 Birch Hollow Rd.
Pikesville, MD 21208 US
Other 510(k) Applications for this Company
Contact
Sathya Elumalai
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2020
Decision Date
02/06/2021
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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