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 Imaging System, Convex Array Transducer, Linear Array.
| Device ID | K101008 |
| 510k Number | K101008 |
| Device Name: | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-12 |
| Decision Date | 2010-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396495046 | K101008 | 000 |
| 06938396494018 | K101008 | 000 |
| 06938396491024 | K101008 | 000 |
| 06938396490041 | K101008 | 000 |
| 06938396488017 | K101008 | 000 |
| 06938396477011 | K101008 | 000 |
| 06938396411008 | K101008 | 000 |