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510(k) K030348

Device
BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
Applicant
BIOLAB EQUIPMENT CANADA LTD.
510(k) number
K030348
Product code
FIP  
Decision
Substantially Equivalent (SESE)
Decision date
2003-10-21
Date received
2003-02-03
Regulation
876.5665
Classification name
Subsystem, Water Purification
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JERRY PONIKVAR
Address
128 Grandview Ave. Thornhill, Ontario CA L3T 1H6 L3T 1H6

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FIP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC2025-11-14
K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC2025-10-09
K252181AquaAFresenius Medical Care North America2025-09-09
K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.2025-03-17
K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC2024-06-13
K223479AQUAbase nXB.Braun Medical, Inc.2023-08-16
K231410RenaPure Endotoxin Retentive FilterEvoqua Water Technologies, LLC2023-07-19
K223656AmeriWater MediQA Reverse Osmosis System (MSP3HF)AmeriWater, LLC2023-02-13
K213507AquaAFresenius Medical Care Rental Therapies Group, LLC2022-07-27
K211035U9000 Plus UltrafilterBaxter Healthcare Corporation2021-10-19
K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc.2020-04-16
K192398Millenium HXMar Cor Purification, Inc.2019-10-03
K182367DIASAFEplusUSFresenius Medical Care Renal Therapies Group, LLC2019-01-10
K171099EON Portable Reverse Osmosis Water Purification SystemCantel2018-01-05
K161304EndoPur FilterNephros, Inc.2017-03-02

Legacy Summary#

summary

FDA Review#

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