510(k) Premarket Notification

• Device Classification Name: electrode, cutaneous
• 510(K) Number: K121483
• Model: 50709 SERIES
• Device Name: REUSABLE CUTANEOUS ELECTRODE
• Applicant: AMPCARE, LLC; 1201 richardson drive; suite 280; richardson, TX 75080
• Contact: diane rutherford
• Regulation Number: 882.1320
• Classification Product Code: GXY
• Date Received: 05/18/2012
• Decision Date: 10/15/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Neurology
• Review Advisory Committee: Neurology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No