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FDA 510(k) Application Details - K193626
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K193626
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
Masimo Corporation
52 Discovery
Irvine, CA 92618 US
Other 510(k) Applications for this Company
Contact
Linus Park
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
12/26/2019
Decision Date
08/10/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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