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FDA 510(k) Application Details - K140862
Device Classification Name
More FDA Info for this Device
510(K) Number
K140862
Device Name
MONICA NOVII WIRELESS PATCH SYSTEM
Applicant
MONICA HEALTHCARE LTD.
BIOCITY, PENNYFOOT STREET
NOTTINGHAM NG1 1GF GB
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Contact
CARL BARRATT
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OSP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/03/2014
Decision Date
08/27/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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