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FDA 510(k)

ASEPTECH PORTABLE RO+ SYSTEM

K-Number: K924695 · 1995-08-24

ApplicantDayton Water Systems
Decision Date1995-08-24
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASEPTECH PORTABLE RO+ SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dayton Water Systems. It received FDA 510(k) clearance on 1995-08-24 under 510(k) number K924695. 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 ASEPTECH PORTABLE RO+ SYSTEM?

ASEPTECH PORTABLE RO+ SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Dayton Water Systems. The 510(k) number is K924695.

When did ASEPTECH PORTABLE RO+ SYSTEM receive FDA 510(k) clearance?

ASEPTECH PORTABLE RO+ SYSTEM received FDA 510(k) clearance on 1995-08-24, under 510(k) number K924695.

Who is the listed applicant for ASEPTECH PORTABLE RO+ SYSTEM?

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

What is the FDA product code for ASEPTECH PORTABLE RO+ SYSTEM?

The FDA product code for ASEPTECH PORTABLE RO+ 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

Other records listing Dayton Water Systems as applicant

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.

K021352DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSISK981680ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS

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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