K040904 is an FDA 510(k) clearance for the PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A. This device is classified as a Over-the-counter Automated External Defibrillator (Class III - Premarket Approval, product code NSA).
Submitted by Philips Medical Systems (Seattle, US). The FDA issued a Cleared decision on September 16, 2004, 162 days after receiving the submission on April 7, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5310. Automated External Defibrillators Are Devices That 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 Over-the-counter Without A Prescription. The Device Is To Be Used On Adults And Children Who Are Either > 8 Years Old Or > 55 Lbs..
| 510(k) Number | K040904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2004 |
| Decision Date | September 16, 2004 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NSA — Over-the-counter Automated External Defibrillator |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.5310 |
| Definition | Automated External Defibrillators Are Devices That 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 Over-the-counter Without A Prescription. The Device Is To Be Used On Adults And Children Who Are Either > 8 Years Old Or > 55 Lbs. |