K791975
Substantially EquivalentPACING SYSTEM ANALYZER PSA SCE-22
- Applicant
- Ela Medical, Inc.
- Product 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.