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FDA 510(k)

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K-Number: K920186 · 1995-06-13

ApplicantBetter Water, Inc.
Decision Date1995-06-13
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Better Water, Inc.. It received FDA 510(k) clearance on 1995-06-13 under 510(k) number K920186. 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 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 1995-06-13. The listed applicant is Better Water, Inc.. The 510(k) number is K920186.

When did WATER PURIFICATION SYSTEM FOR HEMODIALYSIS receive FDA 510(k) clearance?

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance on 1995-06-13, under 510(k) number K920186.

Who is the listed applicant for WATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

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

What is the FDA product code for WATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

The FDA product code for WATER PURIFICATION 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 Better 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.

K051620MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIESK992793SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEMK954928PORTABLE REVERSE OSMOSIS MACHINE

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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