510(k) K082861
K082861 is an FDA 510(k) premarket notification submitted by Amco International Manufacturing & Design, Inc. for the device "AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561". The FDA issued a decision of Substantially Equivalent on Nov 25, 2008. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Amco International Manufacturing & Design, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 25, 2008
- Date Received
- Sep 29, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Automated External Defibrillators (Non-Wearable)
- Device Class
- Class III
- Regulation Number
- 870.5310
- Review Panel
- CV
- Submission Type
- PMA
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.