510(k) K040904
K040904 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A". The FDA issued a decision of Substantially Equivalent on September 16, 2004. The device falls under product code NSA (Over-The-Counter Automated External Defibrillator), a Class III device regulated under 21 CFR 870.5310. Philips Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2004
- Date Received
- April 7, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Automated External Defibrillator
- Device Class
- Class III
- Regulation Number
- 870.5310
- Review Panel
- CV
- Submission Type
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.