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 / Linear / Phased Array Transducer.
| Device ID | K110841 |
| 510k Number | K110841 |
| Device Name: | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI 77 JINSHA ROAD Shantou, Guangdong, CN 515041 |
| Contact | Flower Cai |
| Correspondent | Flower Cai SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI 77 JINSHA ROAD Shantou, Guangdong, CN 515041 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-25 |
| Decision Date | 2011-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396438005 | K110841 | 000 |