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FDA 510(k)

Pall-Aquasafe Water Filter

K-Number: K153434 · 2016-06-10

ApplicantPall International Sarl
Decision Date2016-06-10
Product CodeNHV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pall-Aquasafe Water Filter 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 2016-06-10 under 510(k) number K153434. 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-Aquasafe Water Filter?

Pall-Aquasafe Water Filter is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Pall International Sarl. The 510(k) number is K153434.

When did Pall-Aquasafe Water Filter receive FDA 510(k) clearance?

Pall-Aquasafe Water Filter received FDA 510(k) clearance on 2016-06-10, under 510(k) number K153434.

Who is the listed applicant for Pall-Aquasafe Water Filter?

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-Aquasafe Water Filter?

The FDA product code for Pall-Aquasafe Water Filter 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.

K163609Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)

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.K163609Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)Pall International SarlK161467HydraGuard 10 UltraFilterNephros, Inc.

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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