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.
| Device ID | K212134 |
| 510k Number | K212134 |
| Device Name: | Diagnostic X-ray System/PLX5200A |
| Classification | System, X-ray, Mobile |
| Applicant | Nanjing Perlove Medical Equipment Co., Ltd. No.97&99, Wangxi Road, Jiangning District Nanjing, CN 211100 |
| Contact | Lu Fengfang |
| Correspondent | Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555 Shanghai, CN 200071 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-08 |
| Decision Date | 2021-08-25 |