The following data is part of a premarket notification filed by Zhuhai Pusen Medical Technology Co., Ltd. with the FDA for Pusen Eview Medical Video Endoscope Image Processor.
| Device ID | K190648 |
| 510k Number | K190648 |
| Device Name: | Pusen Eview Medical Video Endoscope Image Processor |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | Zhuhai Pusen Medical Technology Co., Ltd. 5/F, Building 1, No 33, Keji San Road, High-tech Zone Tangjiawan Town, CN 519085 |
| Contact | Wang Changshen |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-03-13 |
| Decision Date | 2019-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971176280135 | K190648 | 000 |
| 06971176280043 | K190648 | 000 |