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FDA 510(k) Application Details - K212134
Device Classification Name
System, X-Ray, Mobile
More FDA Info for this Device
510(K) Number
K212134
Device Name
System, X-Ray, Mobile
Applicant
Nanjing Perlove Medical Equipment Co., Ltd.
No.97&99, Wangxi Road, Jiangning District
Nanjing 211100 CN
Other 510(k) Applications for this Company
Contact
Lu Fengfang
Other 510(k) Applications for this Contact
Regulation Number
892.1720
More FDA Info for this Regulation Number
Classification Product Code
IZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/08/2021
Decision Date
08/25/2021
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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