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FDA 510(k)

AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS

K-Number: K051031 · 2006-01-06

ApplicantAmeriwater
Decision Date2006-01-06
Product CodeFIN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMERIWATER SOLUTION MIX AND DISTRIBUTION 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 2006-01-06 under 510(k) number K051031. The device is classified under product code FIN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS?

AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 2006-01-06. The listed applicant is Ameriwater. The 510(k) number is K051031.

When did AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS receive FDA 510(k) clearance?

AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance on 2006-01-06, under 510(k) number K051031.

Who is the listed applicant for AMERIWATER SOLUTION MIX AND DISTRIBUTION 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 AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS?

The FDA product code for AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS is FIN.

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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 STATIONK021560MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSISK030059PORTABLE RO+ MODEL MROS09

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Related Devices (Code: FIN)

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.

K112427BICARB MIXING AND DISTRIBUTION SYSTEMIsopure, Corp.K093641TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEMTango3, LLCK060333DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEMDialysis Services, Inc.K031502USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEMUsfilterK033118BIPRO MODEL SDS-CB200Medical Solutions InternationalK030366BICARD MIXING SYSTEMDialysis Systems, 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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