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FDA 510(k)

MODEL 418 SERIES WALKERS

K-Number: K053192 · 2005-12-05

ApplicantMjm International Corporation
Decision Date2005-12-05
Product CodeNXE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL 418 SERIES WALKERS is the device name listed in this FDA 510(k) record. The listed applicant is Mjm International Corporation. It received FDA 510(k) clearance on 2005-12-05 under 510(k) number K053192. The device is classified under product code NXE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 418 SERIES WALKERS?

MODEL 418 SERIES WALKERS is a medical device that received FDA 510(k) clearance on 2005-12-05. The listed applicant is Mjm International Corporation. The 510(k) number is K053192.

When did MODEL 418 SERIES WALKERS receive FDA 510(k) clearance?

MODEL 418 SERIES WALKERS received FDA 510(k) clearance on 2005-12-05, under 510(k) number K053192.

Who is the listed applicant for MODEL 418 SERIES WALKERS?

The FDA 510(k) record lists Mjm International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 418 SERIES WALKERS?

The FDA product code for MODEL 418 SERIES WALKERS is NXE.

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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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