MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD

Electrosurgical, Cutting & Coagulation & Accessories

MEGADYNE MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Mega 2000 Soft Dual Cord Patient Return Electrode Pad.

Pre-market Notification Details

• Device ID: K031285
• 510k Number: K031285
• Device Name: MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020
• Contact: Ronda K Magneson
• Correspondent: Ronda K Magneson; MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-23
• Decision Date: 2003-05-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10614559101889	K031285	000
10614559101872	K031285	000