510(k) Premarket Notification

• Device Classification Name: monitor,physiological,patient(without arrhythmia detection or alarms)
• 510(K) Number: K120193
• Models: ANY VIEW A6, ANY VIEW A8, ANYVIEW A3, ANYVIEW A5
• Device Name: ANY VIEW PATIENT MONITORS
• Applicant: GUANGDONG BIOLIGHT MEDITECH CO., LTD; p.o. box 237-023; shanghai,
• Contact: diana hong
• Regulation Number: 870.2300
• Classification Product Code: MWI
• Date Received: 01/23/2012
• Decision Date: 06/29/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No