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FDA 510(k) Application Details - K040392
Device Classification Name
Monitor, Uterine Contraction, External (For Use In Clinic)
More FDA Info for this Device
510(K) Number
K040392
Device Name
Monitor, Uterine Contraction, External (For Use In Clinic)
Applicant
AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HANOVER, MD 21076 US
Other 510(k) Applications for this Company
Contact
GREGORY FALK
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
02/17/2004
Decision Date
09/14/2004
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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