ELECTROFLEX

Electrode, Cutaneous

MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Electroflex.

Pre-market Notification Details

• Device ID: K943126
• 510k Number: K943126
• Device Name: ELECTROFLEX
• Classification: Electrode, Cutaneous
• Applicant: MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112
• Contact: David Kaysen
• Correspondent: David Kaysen; MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-06-29
• Decision Date: 1994-12-05