510(k) K212134
K212134 is an FDA 510(k) premarket notification submitted by Nanjing Perlove Medical Equipment Co., Ltd. for the device "Diagnostic X-ray System/PLX5200A". The FDA issued a decision of Substantially Equivalent on August 25, 2021. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Nanjing Perlove Medical Equipment Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2021
- Date Received
- July 8, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type