FS-500DDR Medical Radiographic X-Ray System
K-Number: K152813 · 2016-12-02
Decision Date2016-12-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FS-500DDR Medical Radiographic X-Ray System is a medical device manufactured by Orich Medical Equipment (Tianjin) Co., Ltd.. It received FDA 510(k) clearance on 2016-12-02 under approval number K152813. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FS-500DDR Medical Radiographic X-Ray System?
FS-500DDR Medical Radiographic X-Ray System is a medical device that received FDA 510(k) clearance on 2016-12-02. It is manufactured by Orich Medical Equipment (Tianjin) Co., Ltd.. The 510(k) number is K152813.
When was FS-500DDR Medical Radiographic X-Ray System approved by the FDA?
FS-500DDR Medical Radiographic X-Ray System received FDA 510(k) clearance on 2016-12-02, under approval number K152813.
What company makes FS-500DDR Medical Radiographic X-Ray System?
FS-500DDR Medical Radiographic X-Ray System is manufactured by Orich Medical Equipment (Tianjin) Co., Ltd..
What is the FDA product code for FS-500DDR Medical Radiographic X-Ray System?
The FDA product code for FS-500DDR Medical Radiographic X-Ray System is KPR.
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Official Source
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