4K UHD Camera System— 510(k) K200216

Substantially Equivalent

Scivita Medical Technology Co., Ltd.

FDA 510(k) clearance K200216 for 4K UHD Camera System, Substantially Equivalent on 2020-08-21. Applicant: Scivita Medical Technology Co., Ltd..

Clearance details

Applicant: Scivita Medical Technology Co., Ltd.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2020-01-28
Decision date: 2020-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.