The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instuments with the FDA for Cts-285 With Ezu-pl21 And Ezu-pc3b Transducers.
| Device ID | K963065 |
| 510k Number | K963065 |
| Device Name: | CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 1106 CHILTERN DR. Walnut Creek, CA 94596 |
| Contact | Robert Morton |
| Correspondent | Robert Morton SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS 1106 CHILTERN DR. Walnut Creek, CA 94596 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-07 |
| Decision Date | 1997-05-29 |
| Summary: | summary |