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FDA 510(k) Application Details - K140163
Device Classification Name
Monitor, Uterine Contraction, External (For Use In Clinic)
More FDA Info for this Device
510(K) Number
K140163
Device Name
Monitor, Uterine Contraction, External (For Use In Clinic)
Applicant
CLINICAL INNOVATIONS, LLC
62 FOREST STREET, STE 300
MARLBOROUGH, MA 01752 US
Other 510(k) Applications for this Company
Contact
JOANNE BRONIKOWSKI
Other 510(k) Applications for this Contact
Regulation Number
884.2720
More FDA Info for this Regulation Number
Classification Product Code
HFM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/22/2014
Decision Date
05/29/2014
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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