K192713

Substantially Equivalent

Altera Filter and HME/Filter

Applicant: Meditera Tibbi Malzeme San VE Tic AS
Product code: CAH
Advisory panel: Anesthesiology
Date received: 2019-09-27
Decision date: 2020-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Izmir, TR

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.