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FDA 510(k) Application Details - K212227
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K212227
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
Invivo Corporation
12151 Research Parkway
Orlando, FL 32826 US
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Contact
Maria Keelan
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
07/16/2021
Decision Date
09/30/2021
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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