510(k) K090777— EZC MEDICAL, LLC INTUBAIDFLEX

Substantially Equivalent

Ezc Medical, LLC

Clearance details

Applicant: Ezc Medical, LLC
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2009-03-23
Decision date: 2009-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.