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FDA 510(k)

PURE WATER, INC.'S WATER PURIFICATION SYSTEMS

K-Number: K992786 · 2000-01-24

ApplicantPure Water, Inc.
Decision Date2000-01-24
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PURE WATER, INC.'S WATER PURIFICATION SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Pure Water, Inc.. It received FDA 510(k) clearance on 2000-01-24 under 510(k) number K992786. 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 PURE WATER, INC.'S WATER PURIFICATION SYSTEMS?

PURE WATER, INC.'S WATER PURIFICATION SYSTEMS is a medical device that received FDA 510(k) clearance on 2000-01-24. The listed applicant is Pure Water, Inc.. The 510(k) number is K992786.

When did PURE WATER, INC.'S WATER PURIFICATION SYSTEMS receive FDA 510(k) clearance?

PURE WATER, INC.'S WATER PURIFICATION SYSTEMS received FDA 510(k) clearance on 2000-01-24, under 510(k) number K992786.

Who is the listed applicant for PURE WATER, INC.'S WATER PURIFICATION SYSTEMS?

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

What is the FDA product code for PURE WATER, INC.'S WATER PURIFICATION SYSTEMS?

The FDA product code for PURE WATER, INC.'S WATER PURIFICATION SYSTEMS is FIP.

Related Clinical Trials

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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Other records listing Pure Water, Inc. 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.

K993272PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEMK993058PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL

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.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.

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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