EzRay Air (Model VEX-P300)
K-Number: K161063 · 2016-09-01
ApplicantVATECH Co., Ltd.
Decision Date2016-09-01
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EzRay Air (Model VEX-P300) is a medical device manufactured by VATECH Co., Ltd.. It received FDA 510(k) clearance on 2016-09-01 under approval number K161063. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EzRay Air (Model VEX-P300)?
EzRay Air (Model VEX-P300) is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by VATECH Co., Ltd.. The 510(k) number is K161063.
When was EzRay Air (Model VEX-P300) approved by the FDA?
EzRay Air (Model VEX-P300) received FDA 510(k) clearance on 2016-09-01, under approval number K161063.
What company makes EzRay Air (Model VEX-P300)?
EzRay Air (Model VEX-P300) is manufactured by VATECH Co., Ltd..
What is the FDA product code for EzRay Air (Model VEX-P300)?
The FDA product code for EzRay Air (Model VEX-P300) is EHD.
Other Devices by VATECH Co., Ltd.
Related Devices (Code: EHD)
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.