The following data is part of a premarket notification filed by Beijing East Whale Imaging Technology Co., Ltd with the FDA for B6.
| Device ID | K163429 |
| 510k Number | K163429 |
| Device Name: | B6 |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | Beijing East Whale Imaging Technology Co., Ltd Unit701, Building1, Yongchang Industrial Park No.3 Yongchang North Rd., BDA Beijing, CN 100176 |
| Contact | Sharon Fan |
| Correspondent | Sharon Fan Beijing East Whale Imaging Technology Co., Ltd Unit701, Building1, Yongchang Industrial Park No.3 Yongchang North Rd., BDA Beijing, CN 100176 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-07 |
| Decision Date | 2017-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970528550063 | K163429 | 000 |