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FDA 510(k)

PORTABLE REVERSE OSMOSIS MACHINE

K-Number: K954928 · 1996-01-24

ApplicantBetter Water, Inc.
Decision Date1996-01-24
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PORTABLE REVERSE OSMOSIS MACHINE 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 1996-01-24 under 510(k) number K954928. 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 PORTABLE REVERSE OSMOSIS MACHINE?

PORTABLE REVERSE OSMOSIS MACHINE is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Better Water, Inc.. The 510(k) number is K954928.

When did PORTABLE REVERSE OSMOSIS MACHINE receive FDA 510(k) clearance?

PORTABLE REVERSE OSMOSIS MACHINE received FDA 510(k) clearance on 1996-01-24, under 510(k) number K954928.

Who is the listed applicant for PORTABLE REVERSE OSMOSIS MACHINE?

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 PORTABLE REVERSE OSMOSIS MACHINE?

The FDA product code for PORTABLE REVERSE OSMOSIS MACHINE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK920186WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

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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