K013425 is an FDA 510(k) clearance for the HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A. This device is classified as a Automated External Defibrillators (non-wearable) (Class III - Premarket Approval, product code MKJ).
Submitted by Philips Medical Systems (Seattle, US). The FDA issued a Cleared decision on January 14, 2002, 90 days after receiving the submission on October 16, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5310. This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only..
| 510(k) Number | K013425 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2001 |
| Decision Date | January 14, 2002 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MKJ — Automated External Defibrillators (non-wearable) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.5310 |
| Definition | This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only. |