AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT— 510(k) K935693

Substantially Equivalent

Vortran Medical Technology 1, Inc.

FDA 510(k) clearance K935693 for AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT, Substantially Equivalent on 1994-08-25. Applicant: Vortran Medical Technology 1, Inc..

Clearance details

Applicant: Vortran Medical Technology 1, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1993-11-29
Decision date: 1994-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.