FDA 510(k)

MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE

K-Number: K080741 · 2008-12-16

ApplicantMegadyne Medical Products, Inc.

Decision Date2008-12-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE 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 2008-12-16 under 510(k) number K080741. 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 SOFT REUSABLE PATIENT RETURN ELECTRODE?

MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K080741.

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

MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE received FDA 510(k) clearance on 2008-12-16, under 510(k) number K080741.

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

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 SOFT REUSABLE PATIENT RETURN ELECTRODE?

The FDA product code for MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE 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 K081791E-Z CLEAN ELECTROSURGICAL 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.