FDA 510(k)

M-LINK

K-Number: K922303 · 1992-12-11

Decision Date1992-12-11

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

M-LINK is the device name listed in this FDA 510(k) record. The listed applicant is Medimage, Inc.. It received FDA 510(k) clearance on 1992-12-11 under 510(k) number K922303. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-LINK?

M-LINK is a medical device that received FDA 510(k) clearance on 1992-12-11. The listed applicant is Medimage, Inc.. The 510(k) number is K922303.

When did M-LINK receive FDA 510(k) clearance?

M-LINK received FDA 510(k) clearance on 1992-12-11, under 510(k) number K922303.

Who is the listed applicant for M-LINK?

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

What is the FDA product code for M-LINK?

The FDA product code for M-LINK is KPS.

Other records listing Medimage, 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.

K946334GALEN K933321DELTAMANAGER

Related Devices (Code: KPS)

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.