The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (siui) with the FDA for Sr-8100 Portable X-ray Unit.
| Device ID | K200637 |
| 510k Number | K200637 |
| Device Name: | SR-8100 Portable X-ray Unit |
| Classification | System, X-ray, Mobile |
| 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 | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-10 |
| Decision Date | 2020-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396481018 | K200637 | 000 |
| 06938396481001 | K200637 | 000 |
| 06938396480059 | K200637 | 000 |
| 06938396480042 | K200637 | 000 |