Diagnostic X-ray System/PLX5200A

System, X-ray, Mobile

Nanjing Perlove Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Nanjing Perlove Medical Equipment Co., Ltd. with the FDA for Diagnostic X-ray System/plx5200a.

Pre-market Notification Details

Device IDK212134
510k NumberK212134
Device Name:Diagnostic X-ray System/PLX5200A
ClassificationSystem, X-ray, Mobile
Applicant Nanjing Perlove Medical Equipment Co., Ltd. No.97&99, Wangxi Road, Jiangning District Nanjing,  CN 211100
ContactLu Fengfang
CorrespondentStuart Situ
Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555 Shanghai,  CN 200071
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-08
Decision Date2021-08-25

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