510(k) Premarket Notification

• Device Classification Name: monitor,physiological,patient(without arrhythmia detection or alarms)
• 510(K) Number: K101571
• Device Name: XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
• Applicant: WITT BIOMEDICAL CORP; 305 north dr.; melbourne, FL 32934
• Contact: james luker
• Regulation Number: 870.2300
• Classification Product Code: MWI
• Subsequent Product Code: DQK
• Date Received: 06/04/2010
• Decision Date: 10/26/2010
• 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