K851628
Substantially EquivalentRMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO
- Applicant
- Eaton Medical Group
- Product code
- DXJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eaton, MI, US
Adverse events under product code DXJ
product code DXJ- Death
- 2
- Total
- 2
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.