FDA 510(k)

MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD

K-Number: K021077 · 2002-04-17

ApplicantMegadyne Medical Products, Inc.

Decision Date2002-04-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD 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 2002-04-17 under 510(k) number K021077. 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 2000 SOFT PATIENT RETURN ELECTRODE PAD?

MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD is a medical device that received FDA 510(k) clearance on 2002-04-17. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K021077.

When did MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD receive FDA 510(k) clearance?

MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD received FDA 510(k) clearance on 2002-04-17, under 510(k) number K021077.

Who is the listed applicant for MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD?

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 2000 SOFT PATIENT RETURN ELECTRODE PAD?

The FDA product code for MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD is GEI.

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Other records listing Megadyne Medical Products, Inc. as applicant

K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)K213696ETHICON Megadyne Electrosurgical Generator K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor K193145Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch K191328Megadyne Foot Switch K080741MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE

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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.