510(k) K003565
K003565 is an FDA 510(k) premarket notification submitted by Agilent Technologies, Inc. for the device "HEARTSTREAM FR2 AED, MODEL M3860A,M3861A". The FDA issued a decision of Substantially Equivalent on December 20, 2000. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Agilent Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2000
- Date Received
- November 20, 2000
- Clearance Type
- Special
- 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
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.