510(k) K003565

HEARTSTREAM FR2 AED, MODEL M3860A,M3861A by Agilent Technologies, Inc. — Product Code MKJ

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.

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K011578 — M2376A DEVICELINK SYSTEM, MODEL M2376A (June 8, 2001)
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K010453 — M2376A DEVICELINK SYSTEM (March 2, 2001)
K010342 — M2376A DEVICELINK SYSTEM, MODEL M2376A (February 14, 2001)

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K133239 — ZOLL E SERIES (January 16, 2015)
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K142915 — ZOLL X Series (December 3, 2014)
K142803 — Skintact, various other tradenames (December 2, 2014)