510(k) K070232— ECG CABLES, TRUNK AND PATIENT LEAD WIRES
Substantially EquivalentAmerican I.V. Products, Inc.
Clearance details
- Applicant
- American I.V. Products, Inc.
- Product code
- Code DSA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Harmans, MD, US
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.