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FDA 510(k)

HEMODIALYSIS SYSTEM AND ACCESSORY

K-Number: K902426 · 1990-11-20

ApplicantGainor Medical Europe, Ltd.
Decision Date1990-11-20
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYSIS SYSTEM AND ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical Europe, Ltd.. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K902426. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMODIALYSIS SYSTEM AND ACCESSORY?

HEMODIALYSIS SYSTEM AND ACCESSORY is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Gainor Medical Europe, Ltd.. The 510(k) number is K902426.

When did HEMODIALYSIS SYSTEM AND ACCESSORY receive FDA 510(k) clearance?

HEMODIALYSIS SYSTEM AND ACCESSORY received FDA 510(k) clearance on 1990-11-20, under 510(k) number K902426.

Who is the listed applicant for HEMODIALYSIS SYSTEM AND ACCESSORY?

The FDA 510(k) record lists Gainor Medical Europe, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMODIALYSIS SYSTEM AND ACCESSORY?

The FDA product code for HEMODIALYSIS SYSTEM AND ACCESSORY is FJK.

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Other records listing Gainor Medical Europe, Ltd. as applicant

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Related Devices (Code: FJK)

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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.

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