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FDA 510(k)

MEDRO SPD

K-Number: K030652 · 2003-09-03

ApplicantUsfilter/Ionpure, Inc.
Decision Date2003-09-03
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDRO SPD 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 2003-09-03 under 510(k) number K030652. 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 MEDRO SPD?

MEDRO SPD is a medical device that received FDA 510(k) clearance on 2003-09-03. The listed applicant is Usfilter/Ionpure, Inc.. The 510(k) number is K030652.

When did MEDRO SPD receive FDA 510(k) clearance?

MEDRO SPD received FDA 510(k) clearance on 2003-09-03, under 510(k) number K030652.

Who is the listed applicant for MEDRO SPD?

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 MEDRO SPD?

The FDA product code for MEDRO SPD 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.

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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.

K013677MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEMK980182WATER 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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