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FDA 510(k)

EzRay Air Portable (Model: VEX-P300)

K-Number: K200182 · 2020-02-11

ApplicantVATECH Co., Ltd.
Decision Date2020-02-11
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EzRay Air Portable (Model: VEX-P300) is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2020-02-11 under 510(k) number K200182. 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 Portable (Model: VEX-P300)?

EzRay Air Portable (Model: VEX-P300) is a medical device that received FDA 510(k) clearance on 2020-02-11. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K200182.

When did EzRay Air Portable (Model: VEX-P300) receive FDA 510(k) clearance?

EzRay Air Portable (Model: VEX-P300) received FDA 510(k) clearance on 2020-02-11, under 510(k) number K200182.

Who is the listed applicant for EzRay Air Portable (Model: VEX-P300)?

The FDA 510(k) record lists VATECH Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EzRay Air Portable (Model: VEX-P300)?

The FDA product code for EzRay Air Portable (Model: VEX-P300) is EHD.

Other records listing VATECH Co., Ltd. as applicant

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Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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