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FDA 510(k) Application Details - K160984
Device Classification Name
More FDA Info for this Device
510(K) Number
K160984
Device Name
MultiScan G-Arm System
Applicant
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD
B2-2 NEW CITY INDUSTRIAL PARK,
NO.9 KECHUANG 2ND ST. YIZHUANG
BEIJING 100023 CN
Other 510(k) Applications for this Company
Contact
SHARON FAN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/07/2016
Decision Date
07/20/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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