PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT— 510(k) K782146
UnknownArco Medical Products Co.
FDA 510(k) clearance K782146 for PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT, Unknown on 1978-12-27. Applicant: Arco Medical Products Co..
Clearance details
- Applicant
- Arco Medical Products Co.
- Product code
- Code DXY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code DXY
product code DXY- Death
- 240
- Injury
- 2,328
- Malfunction
- 2,096
- Total
- 4,664
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.