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FDA 510(k)

FILTRAY 2G Disposable Water Filters

K-Number: K191563 · 2019-10-25

ApplicantAqua-Tools
Decision Date2019-10-25
Product CodeNHV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FILTRAY 2G Disposable Water Filters is the device name listed in this FDA 510(k) record. The listed applicant is Aqua-Tools. It received FDA 510(k) clearance on 2019-10-25 under 510(k) 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. The listed applicant is Aqua-Tools. The 510(k) number is K191563.

When did FILTRAY 2G Disposable Water Filters receive FDA 510(k) clearance?

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

Who is the listed applicant for FILTRAY 2G Disposable Water Filters?

The FDA 510(k) record lists Aqua-Tools as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: NHV)

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.

K222727i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbHK182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower WandEcolab, Inc.K173164Ecolab POU Water FilterEcolab, Inc.K163609Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)Pall International SarlK161467HydraGuard 10 UltraFilterNephros, Inc.K153784NOSOGARD FILTERSEvoqua Water Technologies, LLC

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.

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