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510(k) K860676

HEARTSTART 2000 by First Medical Devices Corp. — Product Code MKJ

K860676 is an FDA 510(k) premarket notification submitted by First Medical Devices Corp. for the device "HEARTSTART 2000". The FDA issued a decision of Substantially Equivalent on April 30, 1986. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. First Medical Devices Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1986
Date Received
February 25, 1986
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 First Medical Devices Corp.

  • K903657 — MODEL 610 MODIFIED (September 4, 1990)
  • K895185 — FIRST MEDIC MODEL 610P (October 27, 1989)
  • K883584 — FIRST MEDIC MODE 610 (October 6, 1988)
  • K880780 — HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG (May 12, 1988)
  • K871136 — HEARTSTART 2000, MANUAL DEFIBRILLATOR (May 12, 1987)
  • K871135 — HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE (May 12, 1987)

Other clearances for product code MKJ

  • K143714 — Powerheart G5 AED (May 4, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (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