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FDA 510(k)

USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM

K-Number: K031502 · 2004-08-27

ApplicantUsfilter
Decision Date2004-08-27
Product CodeFIN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Usfilter. It received FDA 510(k) clearance on 2004-08-27 under 510(k) number K031502. 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 USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM?

USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-27. The listed applicant is Usfilter. The 510(k) number is K031502.

When did USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM receive FDA 510(k) clearance?

USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM received FDA 510(k) clearance on 2004-08-27, under 510(k) number K031502.

Who is the listed applicant for USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM?

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

What is the FDA product code for USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM?

The FDA product code for USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM is FIN.

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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.K051031AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSISAmeriwaterK033118BIPRO MODEL SDS-CB200Medical Solutions InternationalK030366BICARD MIXING SYSTEMDialysis Systems, 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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