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FDA 510(k) Application Details - K112911
Device Classification Name
Monitor, Ultrasonic, Fetal
More FDA Info for this Device
510(K) Number
K112911
Device Name
Monitor, Ultrasonic, Fetal
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
P.O. BOX 237-023
SHANGHAI 200237 CN
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Contact
Diana Hong
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
10/03/2011
Decision Date
10/27/2011
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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