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FDA 510(k) Application Details - K994353
Device Classification Name
Monitor, Uterine Contraction, External (For Use In Clinic)
More FDA Info for this Device
510(K) Number
K994353
Device Name
Monitor, Uterine Contraction, External (For Use In Clinic)
Applicant
PRECISION DYNAMICS CORP.
13880 DEL SUR ST.
SAN FERNANDO, CA 91340-3490 US
Other 510(k) Applications for this Company
Contact
KALYNA SNYLYK
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
12/23/1999
Decision Date
03/22/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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