K050074
Substantially Equivalent12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
- Applicant
- Welch Allyn, Inc.
- Product code
- DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Skaneateles Falls, NY, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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.