Electrocardiograph, model: ECG301— 510(k) K232816
Substantially EquivalentShenzhen LE Medical Technology Co., Ltd.
FDA 510(k) clearance K232816 for Electrocardiograph, model: ECG301, Substantially Equivalent on 2024-06-07. Applicant: Shenzhen LE Medical Technology Co., Ltd..
Clearance details
- Applicant
- Shenzhen LE Medical Technology Co., Ltd.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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.