AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S— 510(k) K770001

Substantially Equivalent

Omnicon Medical Corp.

FDA 510(k) clearance K770001 for AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S, Substantially Equivalent on 1977-01-12. Applicant: Omnicon Medical Corp..

Clearance details

Applicant: Omnicon Medical Corp.
Product code: Code CAE
Advisory panel: Anesthesiology
Date received: 1977-01-03
Decision date: 1977-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MO, US

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Adverse events under product code CAE

product code CAE

Death: 4
Total: 4

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.