The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instuments with the FDA for Cts-7700 Digital Ultrasound Imaging System.
| Device ID | K070982 |
| 510k Number | K070982 |
| Device Name: | CTS-7700 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-06 |
| Decision Date | 2007-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396491116 | K070982 | 000 |
| 06938396490096 | K070982 | 000 |
| 06938396477004 | K070982 | 000 |