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FDA 510(k) Application Details - K150361
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
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510(K) Number
K150361
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
Sotera Wireless, Inc.
10020 Huennekens Street
San Diego, CA 92121 US
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Contact
Carson Krupp
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Regulation Number
870.2300
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Classification Product Code
MWI
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More FDA Info for this Product Code
Date Received
02/12/2015
Decision Date
04/30/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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