FDA 510(k)

E-Z PEN, REUSEABLE HANDSWITCHING PENCIL

K-Number: K050102 · 2005-02-01

ApplicantMegadyne Medical Products, Inc.

Decision Date2005-02-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

E-Z PEN, REUSEABLE HANDSWITCHING PENCIL is the device name listed in this FDA 510(k) record. The listed applicant is Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 2005-02-01 under 510(k) number K050102. 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 E-Z PEN, REUSEABLE HANDSWITCHING PENCIL?

E-Z PEN, REUSEABLE HANDSWITCHING PENCIL is a medical device that received FDA 510(k) clearance on 2005-02-01. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K050102.

When did E-Z PEN, REUSEABLE HANDSWITCHING PENCIL receive FDA 510(k) clearance?

E-Z PEN, REUSEABLE HANDSWITCHING PENCIL received FDA 510(k) clearance on 2005-02-01, under 510(k) number K050102.

Who is the listed applicant for E-Z PEN, REUSEABLE HANDSWITCHING PENCIL?

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

What is the FDA product code for E-Z PEN, REUSEABLE HANDSWITCHING PENCIL?

The FDA product code for E-Z PEN, REUSEABLE HANDSWITCHING PENCIL is GEI.

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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.