The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (siui) with the FDA for Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System.
| Device ID | K173000 |
| 510k Number | K173000 |
| Device Name: | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 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 | 2017-09-27 |
| Decision Date | 2017-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396495084 | K173000 | 000 |
| 06938396421007 | K173000 | 000 |
| 06938396423001 | K173000 | 000 |
| 06938396490256 | K173000 | 000 |
| 06938396491291 | K173000 | 000 |
| 06938396491307 | K173000 | 000 |
| 06938396491321 | K173000 | 000 |
| 06938396492250 | K173000 | 000 |
| 06938396493288 | K173000 | 000 |
| 06938396493295 | K173000 | 000 |
| 06938396493301 | K173000 | 000 |
| 06938396494049 | K173000 | 000 |
| 06938396400576 | K173000 | 000 |