HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A— 510(k) K014157
Substantially Equivalent - Subject to Tracking Reg.Philips Medical Systems
FDA 510(k) clearance K014157 for HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A, Substantially Equivalent - Subject to Tracking Reg. on 2002-01-17. Applicant: Philips Medical Systems.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Code MKJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Special
- Location
- Seattle, 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.