510(k) Premarket Notification

• Device Classification Name: recorder,event,implantable cardiac,(without arrhythmia detection)
• 510(K) Number: K122090
• Model: DM2100
• Device Name: SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
• Applicant: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI; 15900 valley view ct.; sylmar, CA 91342
• Contact: plessy paul
• Regulation Number: 870.2800
• Classification Product Code: MXC
• Subsequent Product Codes: DSH DXH
• Date Received: 07/16/2012
• Decision Date: 11/15/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No