Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIOPURE PORTABLE RO SYSTEMS

K-Number: K112331 · 2012-07-05

ApplicantArion Water, Inc.
Decision Date2012-07-05
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOPURE PORTABLE RO SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Arion Water, Inc.. It received FDA 510(k) clearance on 2012-07-05 under 510(k) number K112331. 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 SYSTEMS?

BIOPURE PORTABLE RO SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-07-05. The listed applicant is Arion Water, Inc.. The 510(k) number is K112331.

When did BIOPURE PORTABLE RO SYSTEMS receive FDA 510(k) clearance?

BIOPURE PORTABLE RO SYSTEMS received FDA 510(k) clearance on 2012-07-05, under 510(k) number K112331.

Who is the listed applicant for BIOPURE PORTABLE RO SYSTEMS?

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

What is the FDA product code for BIOPURE PORTABLE RO SYSTEMS?

The FDA product code for BIOPURE PORTABLE RO SYSTEMS is FIP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑