510(k) Premarket Notification

• Device Classification Name: monitor,physiological,patient(without arrhythmia detection or alarms)
• 510(K) Number: K113183
• Model: PMS8210A MODEL CODE 500
• Device Name: PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
• Applicant: SHANGHAI 3F ELECTRONICS CO LTD; 77325 joyce way; echo, OR 97826
• Contact: charilie mack
• Regulation Number: 870.2300
• Classification Product Code: MWI
• Date Received: 10/28/2011
• Decision Date: 02/09/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Abbreviated
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No