ZOLL R SERIES— 510(k) K081574
Substantially EquivalentZOLL Medical Corporation
FDA 510(k) clearance K081574 for ZOLL R SERIES, Substantially Equivalent on 2008-09-18. Applicant: ZOLL Medical Corporation.
Clearance details
- Applicant
- ZOLL Medical Corporation
- Product code
- Code LDD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chelsmford, MA, US
Adverse events under product code LDD
product code LDD- Death
- 38
- Malfunction
- 522
- Total
- 560
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.