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FDA 510(k)

Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)

K-Number: K163609 · 2017-06-01

ApplicantPall International Sarl
Decision Date2017-06-01
Product CodeNHV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) is the device name listed in this FDA 510(k) record. The listed applicant is Pall International Sarl. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K163609. 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 Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)?

Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Pall International Sarl. The 510(k) number is K163609.

When did Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) receive FDA 510(k) clearance?

Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) received FDA 510(k) clearance on 2017-06-01, under 510(k) number K163609.

Who is the listed applicant for Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)?

The FDA 510(k) record lists Pall International Sarl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)?

The FDA product code for Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) is NHV.

Other records listing Pall International Sarl as applicant

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.

K153434Pall-Aquasafe Water Filter

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 GmbHK191563FILTRAY 2G Disposable Water FiltersAqua-ToolsK182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower WandEcolab, Inc.K173164Ecolab POU Water FilterEcolab, Inc.K161467HydraGuard 10 UltraFilterNephros, Inc.K153784NOSOGARD FILTERSEvoqua Water Technologies, LLC

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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