FDA 510(k)

FILTRAY 2G Disposable Water Filters

K-Number: K191563 · 2019-10-25

Decision Date2019-10-25

Product CodeNHV

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FILTRAY 2G Disposable Water Filters is a medical device manufactured by Aqua-Tools. It received FDA 510(k) clearance on 2019-10-25 under approval number K191563. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILTRAY 2G Disposable Water Filters?

FILTRAY 2G Disposable Water Filters is a medical device that received FDA 510(k) clearance on 2019-10-25. It is manufactured by Aqua-Tools. The 510(k) number is K191563.

When was FILTRAY 2G Disposable Water Filters approved by the FDA?

FILTRAY 2G Disposable Water Filters received FDA 510(k) clearance on 2019-10-25, under approval number K191563.

What company makes FILTRAY 2G Disposable Water Filters?

FILTRAY 2G Disposable Water Filters is manufactured by Aqua-Tools.

What is the FDA product code for FILTRAY 2G Disposable Water Filters?

The FDA product code for FILTRAY 2G Disposable Water Filters is NHV.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.