The following data is part of a premarket notification filed by Benq Medical Technology Corpation with the FDA for Diagnostic Doppler Ultrasound System Curved Linear Array 2-5 Mhz Transducer Linear Array 5-11 Mhz Transducer Phase Arra.
| Device ID | K121983 |
| 510k Number | K121983 |
| Device Name: | DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BENQ MEDICAL TECHNOLOGY CORPATION 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker BENQ MEDICAL TECHNOLOGY CORPATION 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-06 |
| Decision Date | 2012-09-07 |
| Summary: | summary |