FDA 510(k)

MEGA 2000

K-Number: K982826 · 1998-11-06

ApplicantMegadyne Medical Products, Inc.

Decision Date1998-11-06

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MEGA 2000 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 1998-11-06 under 510(k) number K982826. 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?

MEGA 2000 is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K982826.

When did MEGA 2000 receive FDA 510(k) clearance?

MEGA 2000 received FDA 510(k) clearance on 1998-11-06, under 510(k) number K982826.

Who is the listed applicant for MEGA 2000?

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?

The FDA product code for MEGA 2000 is GEI.

Other records listing Megadyne Medical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.