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)

PERFORMANCE WATER TREATMENT SYSTEM

K-Number: K033648 · 2004-08-09

ApplicantPerformance Water Systems, LLC
Decision Date2004-08-09
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERFORMANCE WATER TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Performance Water Systems, LLC. It received FDA 510(k) clearance on 2004-08-09 under 510(k) number K033648. 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 PERFORMANCE WATER TREATMENT SYSTEM?

PERFORMANCE WATER TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-09. The listed applicant is Performance Water Systems, LLC. The 510(k) number is K033648.

When did PERFORMANCE WATER TREATMENT SYSTEM receive FDA 510(k) clearance?

PERFORMANCE WATER TREATMENT SYSTEM received FDA 510(k) clearance on 2004-08-09, under 510(k) number K033648.

Who is the listed applicant for PERFORMANCE WATER TREATMENT SYSTEM?

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

What is the FDA product code for PERFORMANCE WATER TREATMENT SYSTEM?

The FDA product code for PERFORMANCE WATER TREATMENT SYSTEM 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.

↑