510(k) K843808— DUAL CHENNEL BRAIN ACTIVITY MONITOR
Substantially EquivalentDatex Division Instrumentarium Corp.
Clearance details
- Applicant
- Datex Division Instrumentarium Corp.
- Product code
- Code OLT
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Helsinki 10 Finland, US
Adverse events under product code OLT
product code OLT- Other
- 1
- Total
- 1
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.