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FDA 510(k)

MD 420/440/460/470/480/490

K-Number: K993200 · 2000-01-24

ApplicantIsopure, Corp.
Decision Date2000-01-24
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MD 420/440/460/470/480/490 is the device name listed in this FDA 510(k) record. The listed applicant is Isopure, Corp.. It received FDA 510(k) clearance on 2000-01-24 under 510(k) number K993200. 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 MD 420/440/460/470/480/490?

MD 420/440/460/470/480/490 is a medical device that received FDA 510(k) clearance on 2000-01-24. The listed applicant is Isopure, Corp.. The 510(k) number is K993200.

When did MD 420/440/460/470/480/490 receive FDA 510(k) clearance?

MD 420/440/460/470/480/490 received FDA 510(k) clearance on 2000-01-24, under 510(k) number K993200.

Who is the listed applicant for MD 420/440/460/470/480/490?

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

What is the FDA product code for MD 420/440/460/470/480/490?

The FDA product code for MD 420/440/460/470/480/490 is FIP.

Other records listing Isopure, Corp. 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.

K191093Isopure Dry Acid Dissolution SystemK120005ACDSK112427BICARB MIXING AND DISTRIBUTION SYSTEMK041163ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES

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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