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FDA 510(k) Application Details - K191989
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K191989
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
Athena GTX
5900 NW 86th Street, Suite 300
Johnston, IA 50131 US
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Contact
Sean Mahoney
Other 510(k) Applications for this Contact
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
07/25/2019
Decision Date
01/29/2020
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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