510(k) K860949— DUAL-AID
Substantially EquivalentVitalograph , Ltd.
Clearance details
- Applicant
- Vitalograph , Ltd.
- Product code
- Code CAE
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
Adverse events under product code CAE
product code CAE- Death
- 4
- Total
- 4
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.