NSA — Over-The-Counter Automated External Defibrillator Class III
FDA product code NSA covers "Over-The-Counter Automated External Defibrillator", a Class III medical device regulated under 21 CFR 870.5310. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NSA
- Device Class
- Class III
- Regulation Number
- 870.5310
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K040904 | philips medical systems | PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A | September 16, 2004 |