PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR— 510(k) K130684
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K130684 for PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR, Substantially Equivalent on 2013-10-18. Applicant: Philips Medical Systems. Device class: 3.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Code MKJ
- Device class
- Class 3
- Regulation
- 21 CFR 870.5310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Recent devices under product code MKJ
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view all- K212704 — Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
- K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K210560 — Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
- K191738 — PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
- K192875 — Philips Biosensor BX100
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 →
Recalls naming K130684
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130684.
Data sourced from openFDA. This site is unofficial and independent of the FDA.