Digital Electrocardiograph— 510(k) K171517
Substantially EquivalentBiocare Bio-Medical Equipment Co., Ltd.
FDA 510(k) clearance K171517 for Digital Electrocardiograph, Substantially Equivalent on 2018-01-11. Applicant: Biocare Bio-Medical Equipment Co., Ltd..
Clearance details
- Applicant
- Biocare Bio-Medical Equipment Co., Ltd.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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.