Portable ECG Monitor— 510(k) K170954
Substantially EquivalentContec Medical Systems Co.,Ltd
FDA 510(k) clearance K170954 for Portable ECG Monitor, Substantially Equivalent on 2017-05-30. Applicant: Contec Medical Systems Co.,Ltd.
Clearance details
- Applicant
- Contec Medical Systems Co.,Ltd
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Qinhuangdao, 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.