The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instuments with the FDA for Siui Apogee 800plus Ultrasound Imaging System.
| Device ID | K984203 |
| 510k Number | K984203 |
| Device Name: | SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, 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 | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-24 |
| Decision Date | 1999-11-01 |
| Summary: | summary |