FDA 510(k)

MEGA POWER ELECTROSURGICAL GENERATOR

K-Number: K050579 · 2005-03-24

ApplicantMegadyne Medical Products, Inc.

Decision Date2005-03-24

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MEGA POWER ELECTROSURGICAL GENERATOR 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 2005-03-24 under 510(k) number K050579. 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 MEGA POWER ELECTROSURGICAL GENERATOR?

MEGA POWER ELECTROSURGICAL GENERATOR is a medical device that received FDA 510(k) clearance on 2005-03-24. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K050579.

When did MEGA POWER ELECTROSURGICAL GENERATOR receive FDA 510(k) clearance?

MEGA POWER ELECTROSURGICAL GENERATOR received FDA 510(k) clearance on 2005-03-24, under 510(k) number K050579.

Who is the listed applicant for MEGA POWER ELECTROSURGICAL GENERATOR?

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 MEGA POWER ELECTROSURGICAL GENERATOR?

The FDA product code for MEGA POWER ELECTROSURGICAL GENERATOR is GEI.

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Other records listing Megadyne Medical Products, Inc. as applicant

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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.