FDA 510(k)

PENCIL

K-Number: K965054 · 1997-01-24

ApplicantMegadyne Medical Products, Inc.

Decision Date1997-01-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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 1997-01-24 under 510(k) number K965054. 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 PENCIL?

PENCIL is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K965054.

When did PENCIL receive FDA 510(k) clearance?

PENCIL received FDA 510(k) clearance on 1997-01-24, under 510(k) number K965054.

Who is the listed applicant for 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 PENCIL?

The FDA product code for PENCIL is GEI.

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Other records listing Megadyne Medical Products, Inc. as applicant

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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.