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FDA 510(k)

PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM

K-Number: K993272 · 2000-04-10

ApplicantPure Water, Inc.
Decision Date2000-04-10
Product CodeFIN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pure Water, Inc.. It received FDA 510(k) clearance on 2000-04-10 under 510(k) number K993272. 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 PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM?

PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM is a medical device that received FDA 510(k) clearance on 2000-04-10. The listed applicant is Pure Water, Inc.. The 510(k) number is K993272.

When did PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM receive FDA 510(k) clearance?

PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM received FDA 510(k) clearance on 2000-04-10, under 510(k) number K993272.

Who is the listed applicant for PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM?

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

What is the FDA product code for PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM?

The FDA product code for PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM is FIN.

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.

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Other records listing Pure 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.

K992786PURE WATER, INC.'S WATER PURIFICATION SYSTEMSK993058PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL

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 HEMODIALYSISAmeriwaterK031502USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEMUsfilterK033118BIPRO MODEL SDS-CB200Medical Solutions International

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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