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FDA 510(k)

HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM

K-Number: K022747 · 2003-02-11

ApplicantHydropure Systems, Inc.
Decision Date2003-02-11
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hydropure Systems, Inc.. It received FDA 510(k) clearance on 2003-02-11 under 510(k) number K022747. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM?

HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM is a medical device that received FDA 510(k) clearance on 2003-02-11. The listed applicant is Hydropure Systems, Inc.. The 510(k) number is K022747.

When did HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM receive FDA 510(k) clearance?

HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM received FDA 510(k) clearance on 2003-02-11, under 510(k) number K022747.

Who is the listed applicant for HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM?

The FDA 510(k) record lists Hydropure Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM?

The FDA product code for HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM is FIP.

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Related Devices (Code: FIP)

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.

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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.

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