K000638 is an FDA 510(k) clearance for the RESPONDER 3000. This device is classified as a Automated External Defibrillators (non-wearable) (Class III - Premarket Approval, product code MKJ).
Submitted by Ge Medical Systems Information Technologies GmbH (Freiburg, DE). The FDA issued a Cleared decision on October 30, 2000, 248 days after receiving the submission on February 25, 2000.
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 | K000638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2000 |
| Decision Date | October 30, 2000 |
| Days to Decision | 248 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. |