Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
K-Number: K182715 · 2018-11-20
Decision Date2018-11-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2018-11-20 under approval number K182715. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System?
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-11-20. It is manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd.. The 510(k) number is K182715.
When was Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System approved by the FDA?
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-11-20, under approval number K182715.
What company makes Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System?
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System is manufactured by Shenzhen Wisonic Medical Technology Co. , Ltd..
What is the FDA product code for Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System?
The FDA product code for Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.