LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES— 510(k) K002445
Substantially Equivalent - Subject to Tracking Reg.Medtronic Physio-Control Corp.
FDA 510(k) clearance K002445 for LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES, Substantially Equivalent - Subject to Tracking Reg. on 2001-01-31. Applicant: Medtronic Physio-Control Corp..
Clearance details
- Applicant
- Medtronic Physio-Control Corp.
- Product code
- Code MKJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Redmond, WA, 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.