Alio— 510(k) K223073

Substantially Equivalent

Alio, Inc.

FDA 510(k) clearance K223073 for Alio, Substantially Equivalent on 2023-03-17. Applicant: Alio, Inc..

Clearance details

Applicant: Alio, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2022-09-30
Decision date: 2023-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

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.