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FDA 510(k)

MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM

K-Number: K013677 · 2002-03-08

ApplicantUsfilter/Ionpure, Inc.
Decision Date2002-03-08
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Usfilter/Ionpure, Inc.. It received FDA 510(k) clearance on 2002-03-08 under 510(k) number K013677. 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 MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM?

MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Usfilter/Ionpure, Inc.. The 510(k) number is K013677.

When did MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM received FDA 510(k) clearance on 2002-03-08, under 510(k) number K013677.

Who is the listed applicant for MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM?

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

What is the FDA product code for MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM?

The FDA product code for MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM is FIP.

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Other records listing Usfilter/Ionpure, Inc. 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.

K030652MEDRO SPDK980182WATER PURIFICATION 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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