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FDA 510(k) Application Details - K183332
Device Classification Name
System, Applicator, Radionuclide, Remote-Controlled
More FDA Info for this Device
510(K) Number
K183332
Device Name
System, Applicator, Radionuclide, Remote-Controlled
Applicant
BRAXX Biotech Co. Ltd
6F., No.10, Songde Rd., Xinyi Dist
Taipei City 11076 TW
Other 510(k) Applications for this Company
Contact
Judy Kao
Other 510(k) Applications for this Contact
Regulation Number
892.5700
More FDA Info for this Regulation Number
Classification Product Code
JAQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/03/2018
Decision Date
04/16/2019
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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