Device Classification Name |
Coil, Magnetic Resonance, Specialty
More FDA Info for this Device |
510(K) Number |
K151653 |
Device Name |
Coil, Magnetic Resonance, Specialty |
Applicant |
SHENZHEN RFTECH CO., LTD.
2-F, BLDG 4, JUHUI INDUSTRIAL PARK, TIANLIAO, GUANGMING,
SHENZHEN 51832 CN
Other 510(k) Applications for this Company
|
Contact |
KE XI
Other 510(k) Applications for this Contact |
Regulation Number |
892.1000
More FDA Info for this Regulation Number |
Classification Product Code |
MOS
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/18/2015 |
Decision Date |
08/07/2015 |
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 |
|