The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instuments with the FDA for Digital Color Doppler Ultrasound Imaging System.
| Device ID | K113613 |
| 510k Number | K113613 |
| Device Name: | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 77 JINSHA RD. Shantou, Sez, CN 515041 |
| Contact | Flower Cai |
| Correspondent | Flower Cai SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 77 JINSHA RD. Shantou, Sez, CN 515041 |
| 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 | 2011-12-06 |
| Decision Date | 2012-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396493172 | K113613 | 000 |
| 06938396491314 | K113613 | 000 |
| 06938396412005 | K113613 | 000 |