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FDA 510(k)

BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE

K-Number: K030348 · 2003-10-21

ApplicantBiolab Equipment Canada , Ltd.
Decision Date2003-10-21
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE is the device name listed in this FDA 510(k) record. The listed applicant is Biolab Equipment Canada , Ltd.. It received FDA 510(k) clearance on 2003-10-21 under 510(k) number K030348. 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 BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE?

BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE is a medical device that received FDA 510(k) clearance on 2003-10-21. The listed applicant is Biolab Equipment Canada , Ltd.. The 510(k) number is K030348.

When did BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE receive FDA 510(k) clearance?

BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE received FDA 510(k) clearance on 2003-10-21, under 510(k) number K030348.

Who is the listed applicant for BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE?

The FDA 510(k) record lists Biolab Equipment Canada , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE?

The FDA product code for BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE is FIP.

Related Clinical Trials

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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

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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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