AirLife Adult Heated Wire BiPAP/NIV Circuit— 510(k) K170378
Substantially EquivalentVyaire Medical
FDA 510(k) clearance K170378 for AirLife Adult Heated Wire BiPAP/NIV Circuit, Substantially Equivalent on 2017-09-14. Applicant: Vyaire Medical.
Clearance details
- Applicant
- Vyaire Medical
- Product code
- Code BZE
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
Adverse events under product code BZE
product code BZE- Death
- 4
- Malfunction
- 910
- Other
- 1
- Total
- 915
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.