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FDA 510(k)

Megadyne 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)

K-Number: K233644 · 2024-07-12

ApplicantMegadyne Medical Products, Inc.
Decision Date2024-07-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Megadyne 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) is a medical device manufactured by Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 2024-07-12 under approval number K233644. 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 Megadyne 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)?

Megadyne 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) is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Megadyne Medical Products, Inc.. The 510(k) number is K233644.

When was Megadyne 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) approved by the FDA?

Megadyne 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) received FDA 510(k) clearance on 2024-07-12, under approval number K233644.

What company makes Megadyne 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)?

Megadyne 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) is manufactured by Megadyne Medical Products, Inc..

What is the FDA product code for Megadyne 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)?

The FDA product code for Megadyne 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) is GEI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

Other Devices by Megadyne Medical Products, Inc.

K191328Megadyne Foot Switch 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 K213696ETHICON Megadyne Electrosurgical Generator

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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.

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