Apache Ultrasound System (Model C62)— 510(k) K202074

Substantially Equivalent

Compal Electronics, Inc.

FDA 510(k) clearance K202074 for Apache Ultrasound System (Model C62), Substantially Equivalent on 2020-11-12. Applicant: Compal Electronics, Inc..

Clearance details

Applicant: Compal Electronics, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2020-07-27
Decision date: 2020-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.