ANNE View, Central Hub— 510(k) K242842

Substantially Equivalent

Sibel Health, Inc.

FDA 510(k) clearance K242842 for ANNE View, Central Hub, Substantially Equivalent on 2025-01-08. Applicant: Sibel Health, Inc..

Clearance details

Applicant: Sibel Health, Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2024-09-19
Decision date: 2025-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.