The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instruments Co., Ltd (siui) with the FDA for Apogee 5500/apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System.
| Device ID | K160853 |
| 510k Number | K160853 |
| Device Name: | Apogee 5500/Apogee 5300/ Apogee 5800 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 | 2016-03-28 |
| Decision Date | 2016-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396493189 | K160853 | 000 |
| 06938396492205 | K160853 | 000 |
| 06938396491208 | K160853 | 000 |
| 06938396458003 | K160853 | 000 |
| 06938396455019 | K160853 | 000 |
| 06938396453008 | K160853 | 000 |
| 06938396400811 | K160853 | 000 |
| 06938396400545 | K160853 | 000 |
| 06938396400521 | K160853 | 000 |