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FDA 510(k) Application Details - K023143
Device Classification Name
Monitor, Ultrasonic, Fetal
More FDA Info for this Device
510(K) Number
K023143
Device Name
Monitor, Ultrasonic, Fetal
Applicant
KOVEN TECHNOLOGY, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071-3404 US
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Contact
J. HARVEY KNAUSS
Other 510(k) Applications for this Contact
Regulation Number
884.2660
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Classification Product Code
KNG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/2002
Decision Date
12/19/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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