K811987
Substantially EquivalentOXY-QUIK MARK IV OXYGEN INHALATOR
- Applicant
- Oxequip Health Ind.
- Product code
- DRM
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code DRM
product code DRM- Death
- 82
- Injury
- 126
- Malfunction
- 4,539
- Total
- 4,747
Source: openFDA MAUDE database, through . 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.