The following data is part of a premarket notification filed by Shantou I Nstitute Of Ultrasonic Instruments (siui with the FDA for Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array Transducer.
| Device ID | K103144 |
| 510k Number | K103144 |
| Device Name: | DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI 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 | 2010-10-25 |
| Decision Date | 2011-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396495053 | K103144 | 000 |
| 06938396494032 | K103144 | 000 |
| 06938396491192 | K103144 | 000 |
| 06938396490171 | K103144 | 000 |
| 06938396410001 | K103144 | 000 |