510(k) Premarket Notification

• Device Classification Name: monitor,physiological,patient(without arrhythmia detection or alarms)
• 510(K) Number: K053193
• Device Name: PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
• Applicant: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 55 northern blvd., suite 200; great neck, NY 11021
• Contact: susan d goldstein - falk
• Regulation Number: 870.2300
• Classification Product Code: MWI
• Date Received: 11/15/2005
• Decision Date: 05/18/2006
• 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