PALM ECG RECORDER, MODEL EP-201/202— 510(k) K061123
Substantially EquivalentParama-Tech Company., Ltd.
FDA 510(k) clearance K061123 for PALM ECG RECORDER, MODEL EP-201/202, Substantially Equivalent on 2007-06-29. Applicant: Parama-Tech Company., Ltd..
Clearance details
- Applicant
- Parama-Tech Company., Ltd.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, 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.