Caremed patient cable and leadwires— 510(k) K153188
Substantially EquivalentShenzhen Caremed Medical Technology Co., Ltd.
FDA 510(k) clearance K153188 for Caremed patient cable and leadwires, Substantially Equivalent on 2016-10-24. Applicant: Shenzhen Caremed Medical Technology Co., Ltd..
Clearance details
- Applicant
- Shenzhen Caremed Medical Technology Co., Ltd.
- Product code
- Code DSA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
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.