K193411

Substantially Equivalent

O2asis Personal Oxygen Humidifier

Applicant: Perma Pure, LLC
Product code: BTT
Advisory panel: Anesthesiology
Date received: 2019-12-09
Decision date: 2020-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, NJ, US

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.