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FDA 510(k)

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K-Number: K021560 · 2003-08-14

ApplicantAmeriwater
Decision Date2003-08-14
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Ameriwater. It received FDA 510(k) clearance on 2003-08-14 under 510(k) number K021560. 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 MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 2003-08-14. The listed applicant is Ameriwater. The 510(k) number is K021560.

When did MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS receive FDA 510(k) clearance?

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance on 2003-08-14, under 510(k) number K021560.

Who is the listed applicant for MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

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

What is the FDA product code for MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

The FDA product code for MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS is FIP.

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Other records listing Ameriwater 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.

K131904MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SAK131622MROZ REVERSE OSMOSIS SYSTEMK121022AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIVK111740AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATIONK051031AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSISK030059PORTABLE RO+ MODEL MROS09

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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.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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