MODEL 674 PACER ANALYZER— 510(k) K792074
Substantially EquivalentDel Mar Avionics
FDA 510(k) clearance K792074 for MODEL 674 PACER ANALYZER, Substantially Equivalent on 1979-12-27. Applicant: Del Mar Avionics.
Clearance details
- Applicant
- Del Mar Avionics
- Product code
- Code DTC
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code DTC
product code DTC- Injury
- 136
- Malfunction
- 3,400
- Total
- 3,536
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.