510(k) K221530— ANNE Pediatric

Substantially Equivalent

Sibel, Inc.

Clearance details

Applicant: Sibel, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2022-05-26
Decision date: 2022-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.