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FDA 510(k)

LM-90 ESU

K-Number: K913799 · 1992-01-27

ApplicantKeisegang Medical, Inc.
Decision Date1992-01-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LM-90 ESU is the device name listed in this FDA 510(k) record. The listed applicant is Keisegang Medical, Inc.. It received FDA 510(k) clearance on 1992-01-27 under 510(k) number K913799. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LM-90 ESU?

LM-90 ESU is a medical device that received FDA 510(k) clearance on 1992-01-27. The listed applicant is Keisegang Medical, Inc.. The 510(k) number is K913799.

When did LM-90 ESU receive FDA 510(k) clearance?

LM-90 ESU received FDA 510(k) clearance on 1992-01-27, under 510(k) number K913799.

Who is the listed applicant for LM-90 ESU?

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

What is the FDA product code for LM-90 ESU?

The FDA product code for LM-90 ESU is GEI.

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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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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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