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FDA 510(k)

Green Smart (Model: PHT-35LHS)

K-Number: K162660 · 2016-10-20

ApplicantVATECH Co., Ltd.
Decision Date2016-10-20
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Green Smart (Model: PHT-35LHS) is a medical device manufactured by VATECH Co., Ltd.. It received FDA 510(k) clearance on 2016-10-20 under approval number K162660. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Green Smart (Model: PHT-35LHS)?

Green Smart (Model: PHT-35LHS) is a medical device that received FDA 510(k) clearance on 2016-10-20. It is manufactured by VATECH Co., Ltd.. The 510(k) number is K162660.

When was Green Smart (Model: PHT-35LHS) approved by the FDA?

Green Smart (Model: PHT-35LHS) received FDA 510(k) clearance on 2016-10-20, under approval number K162660.

What company makes Green Smart (Model: PHT-35LHS)?

Green Smart (Model: PHT-35LHS) is manufactured by VATECH Co., Ltd..

What is the FDA product code for Green Smart (Model: PHT-35LHS)?

The FDA product code for Green Smart (Model: PHT-35LHS) is OAS.

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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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