510(k) Premarket Notification

• Device Classification Name: transmitters and receivers, electrocardiograph, telephone
• 510(K) Number: K122184
• Model: ECG01-4S
• Device Name: ECG CHECK
• Applicant: CARDIAC DESIGNS, LLC; 3293 niblick drive; park city, UT 84098
• Contact: karim marrouche
• Regulation Number: 870.2920
• Classification Product Code: DXH
• Date Received: 07/23/2012
• Decision Date: 02/14/2013
• 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