Home / 510(k) Clearances / K010634

510(k) K010634

HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B by Agilent Technologies, Inc. — Product Code MKJ

K010634 is an FDA 510(k) premarket notification submitted by Agilent Technologies, Inc. for the device "HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B". The FDA issued a decision of Substantially Equivalent on June 11, 2001. 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
June 11, 2001
Date Received
March 2, 2001
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

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.

Other clearances by Agilent Technologies, Inc.

  • K163367 — GenetiSure Dx Postnatal Assay (August 11, 2017)
  • K010949 — 2010 PLUS HOLTER FOR WINDOWS (September 28, 2001)
  • K012094 — MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A (July 20, 2001)
  • K011824 — AGILENT M2636B TELEMON B MONITOR (TELEMON B) (July 2, 2001)
  • K011578 — M2376A DEVICELINK SYSTEM, MODEL M2376A (June 8, 2001)
  • K003819 — HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A (May 2, 2001)
  • K011093 — AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 (May 1, 2001)
  • K010453 — M2376A DEVICELINK SYSTEM (March 2, 2001)
  • K010342 — M2376A DEVICELINK SYSTEM, MODEL M2376A (February 14, 2001)
  • K003940 — 2010 PLUS HOLTER FOR WINDOWS (February 8, 2001)

Other clearances for product code MKJ

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K142709 — samaritan PAD 450P (March 27, 2015)
  • K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (January 23, 2015)
  • K133239 — ZOLL E SERIES (January 16, 2015)
  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
  • K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (December 8, 2014)
  • K142915 — ZOLL X Series (December 3, 2014)
  • K142803 — Skintact, various other tradenames (December 2, 2014)

FDA data resources