SafeBreath Filter Mouthpiece— 510(k) K190022

Name: FDA 510(k) clearance K190022
Creator: U.S. Food and Drug Administration
Published: 2019-09-25

Substantially Equivalent

MD Diagnostics Limited

FDA 510(k) clearance K190022 for SafeBreath Filter Mouthpiece, Substantially Equivalent on 2019-09-25. Applicant: MD Diagnostics Limited. Device class: 2.

Clearance details

Applicant: MD Diagnostics Limited
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
Advisory panel: Anesthesiology
Date received: 2019-01-04
Decision date: 2019-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maidstone, GB

Download summary PDF View on FDA.gov ↗

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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.