Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K131777
Device Classification Name
System, Radiation Therapy, Radionuclide
More FDA Info for this Device
510(K) Number
K131777
Device Name
System, Radiation Therapy, Radionuclide
Applicant
HYPER TECHNOLOGY INC
P.O. BOX 120-119
SHANGHAI 200120 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
892.5750
More FDA Info for this Regulation Number
Classification Product Code
IWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/17/2013
Decision Date
02/28/2014
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact