The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (siui) with the FDA for Apogee 1000/ Apogee 1000neo/ Apogee 1000lite/ Apogee 1000exp/ Apogee 1000b/w / Apogee 1u/ Apogee 1t/ Apogee 1g Digital Color Doppler Ultrasound Imaging System.
| Device ID | K210317 |
| 510k Number | K210317 |
| Device Name: | Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou, CN 515041 |
| Contact | Flower Cai |
| Correspondent | Flower Cai Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou, CN 515041 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-03 |
| Decision Date | 2021-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396494070 | K210317 | 000 |
| 06938396491338 | K210317 | 000 |
| 06938396410094 | K210317 | 000 |
| 06938396410087 | K210317 | 000 |
| 06938396410070 | K210317 | 000 |
| 06938396410056 | K210317 | 000 |
| 06938396400132 | K210317 | 000 |
| 06938396400118 | K210317 | 000 |
| 06938396400125 | K210317 | 000 |