The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instuments with the FDA for Cts-485 Ultrasound Imaging System.
| Device ID | K012772 |
| 510k Number | K012772 |
| Device Name: | CTS-485 ULTRASOUND IMAGING SYSTEM |
| 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 | 2001-08-17 |
| Decision Date | 2001-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396491147 | K012772 | 000 |
| 06938396490126 | K012772 | 000 |
| 06938396404857 | K012772 | 000 |