ZOLL M SERIES 12SL ANALYSIS OPTION— 510(k) K991556
Substantially Equivalent - Subject to Tracking Reg.Zoll Medical Corp
FDA 510(k) clearance K991556 for ZOLL M SERIES 12SL ANALYSIS OPTION, Substantially Equivalent - Subject to Tracking Reg. on 1999-10-21. Applicant: Zoll Medical Corp.
Clearance details
- Applicant
- Zoll Medical Corp
- Product code
- Code MKJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Burlington, MA, US
Adverse events under product code MKJ
product code MKJ- Death
- 961
- Injury
- 1,070
- Malfunction
- 90,719
- Other
- 8
- Total
- 92,758
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.