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FDA 510(k)

H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K-Number: K993520 · 2000-05-03

ApplicantServ-A-Pure Co.
Decision Date2000-05-03
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Serv-A-Pure Co.. It received FDA 510(k) clearance on 2000-05-03 under 510(k) number K993520. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 2000-05-03. The listed applicant is Serv-A-Pure Co.. The 510(k) number is K993520.

When did H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS receive FDA 510(k) clearance?

H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance on 2000-05-03, under 510(k) number K993520.

Who is the listed applicant for H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

The FDA 510(k) record lists Serv-A-Pure Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS?

The FDA product code for H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is FIP.

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Related Devices (Code: FIP)

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.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, 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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