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FDA 510(k) Application Details - K221706
Device Classification Name
More FDA Info for this Device
510(K) Number
K221706
Device Name
AccuContour
Applicant
Manteia Technologies Co., Ltd.
1903, B Tower, Zijin Plaza
No. 1811 Huandao East Road
Xiamen 361001 CN
Other 510(k) Applications for this Company
Contact
Dandan Chen
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/13/2022
Decision Date
03/09/2023
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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