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FDA 510(k)

BICARB MIXING AND DISTRIBUTION SYSTEM

K-Number: K112427 · 2012-01-26

ApplicantIsopure, Corp.
Decision Date2012-01-26
Product CodeFIN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BICARB MIXING AND DISTRIBUTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Isopure, Corp.. It received FDA 510(k) clearance on 2012-01-26 under 510(k) number K112427. 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 BICARB MIXING AND DISTRIBUTION SYSTEM?

BICARB MIXING AND DISTRIBUTION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-26. The listed applicant is Isopure, Corp.. The 510(k) number is K112427.

When did BICARB MIXING AND DISTRIBUTION SYSTEM receive FDA 510(k) clearance?

BICARB MIXING AND DISTRIBUTION SYSTEM received FDA 510(k) clearance on 2012-01-26, under 510(k) number K112427.

Who is the listed applicant for BICARB MIXING AND DISTRIBUTION SYSTEM?

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

What is the FDA product code for BICARB MIXING AND DISTRIBUTION SYSTEM?

The FDA product code for BICARB MIXING AND DISTRIBUTION SYSTEM is FIN.

Related Clinical Trials

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Other records listing Isopure, Corp. 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.

K191093Isopure Dry Acid Dissolution SystemK120005ACDSK041163ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIESK993200MD 420/440/460/470/480/490

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.

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 HEMODIALYSISAmeriwaterK031502USFILTER 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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