The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (siui) with the FDA for Apogee 6500,apogee 6300,apogee 6200 Digital Color Doppler Ultrasound Imaging System.
| Device ID | K210318 |
| 510k Number | K210318 |
| Device Name: | Apogee 6500,Apogee 6300,Apogee 6200 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 | 2021-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396494063 | K210318 | 000 |
| 06938396493219 | K210318 | 000 |
| 06938396465001 | K210318 | 000 |
| 06938396463007 | K210318 | 000 |
| 06938396462000 | K210318 | 000 |
| 06938396400408 | K210318 | 000 |