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FDA 510(k)

PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS

K-Number: K011005 · 2002-11-01

ApplicantPure Water Solutions, Inc.
Decision Date2002-11-01
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Pure Water Solutions, Inc.. It received FDA 510(k) clearance on 2002-11-01 under 510(k) number K011005. 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 SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS?

PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 2002-11-01. The listed applicant is Pure Water Solutions, Inc.. The 510(k) number is K011005.

When did PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS receive FDA 510(k) clearance?

PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance on 2002-11-01, under 510(k) number K011005.

Who is the listed applicant for PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS?

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

What is the FDA product code for PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS?

The FDA product code for PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS 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 Solutions, 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.

K994279PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)

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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