510(k) K190022— SafeBreath Filter Mouthpiece

Substantially Equivalent

MD Diagnostics Limited

Clearance details

Applicant: MD Diagnostics Limited
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2019-01-04
Decision date: 2019-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maidstone, GB

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.