K020715 is an FDA 510(k) clearance for the PHILIPS M5066A AND M5068A. 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 November 8, 2002, 248 days after receiving the submission on March 5, 2002.
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 | K020715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | March 05, 2002 |
| Decision Date | November 08, 2002 |
| Days to Decision | 248 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| 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. |