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FDA 510(k)

SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM

K-Number: K992793 · 1999-11-16

ApplicantBetter Water, Inc.
Decision Date1999-11-16
Product CodeFIN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Better Water, Inc.. It received FDA 510(k) clearance on 1999-11-16 under 510(k) number K992793. 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 SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM?

SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-11-16. The listed applicant is Better Water, Inc.. The 510(k) number is K992793.

When did SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM receive FDA 510(k) clearance?

SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM received FDA 510(k) clearance on 1999-11-16, under 510(k) number K992793.

Who is the listed applicant for SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM?

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

What is the FDA product code for SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM?

The FDA product code for SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM is FIN.

Related Clinical Trials

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Other records listing Better 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.

K051620MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIESK954928PORTABLE REVERSE OSMOSIS MACHINEK920186WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

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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