AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM— 510(k) K140097

Name: FDA 510(k) clearance K140097
Creator: U.S. Food and Drug Administration
Published: 2014-09-24

Substantially Equivalent

Applied Medical Technology, Inc.

FDA 510(k) clearance K140097 for AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM, Substantially Equivalent on 2014-09-24. Applicant: Applied Medical Technology, Inc.. Device class: 1.

Clearance details

Applicant: Applied Medical Technology, Inc.
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 2014-01-14
Decision date: 2014-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brecksville, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBH

product code CBH

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.