The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instuments with the FDA for Siui Cts-900 Digital Ultrasound Imaging System.
| Device ID | K081110 |
| 510k Number | K081110 |
| Device Name: | SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-18 |
| Decision Date | 2008-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396409005 | K081110 | 000 |