510(k) Premarket Notification

• Device Classification Name: system, imaging, pulsed doppler, ultrasonic
• 510(K) Number: K121983
• Models: C52, L115, P42, UP600
• Device Name: DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA
• Applicant: BENQ MEDICAL TECHNOLOGY CORPATION; 7263 cronin circle; dublin, CA 94568
• Contact: bob leiker
• Regulation Number: 892.1550
• Classification Product Code: IYN
• Subsequent Product Codes: ITX IYO
• Date Received: 07/06/2012
• Decision Date: 09/07/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Radiology
• Review Advisory Committee: Radiology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No