Deployable Oxygen Generation System-Smaill (DOGS-S)— 510(k) K150930

Substantially Equivalent

Airsep Corporation

FDA 510(k) clearance K150930 for Deployable Oxygen Generation System-Smaill (DOGS-S), Substantially Equivalent on 2015-12-18. Applicant: Airsep Corporation.

Clearance details

Applicant: Airsep Corporation
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2015-04-06
Decision date: 2015-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.