Pusen Eview Medical Video Endoscope Image Processor— 510(k) K190648

Substantially Equivalent

Zhuhai Pusen Medical Technology Co., Ltd.

FDA 510(k) clearance K190648 for Pusen Eview Medical Video Endoscope Image Processor, Substantially Equivalent on 2019-03-29. Applicant: Zhuhai Pusen Medical Technology Co., Ltd..

Clearance details

Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-13
Decision date: 2019-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tangjiawan Town, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.