The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instuments with the FDA for Cts-7700.
| Device ID | K061083 |
| 510k Number | K061083 |
| Device Name: | CTS-7700 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 473 SAPENA COURT SUITE #26 Santa Clara, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 473 SAPENA COURT SUITE #26 Santa Clara, 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 | 2006-04-18 |
| Decision Date | 2006-06-06 |
| Summary: | summary |