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510(k) K870622

HEART*AID 1000 by Cardiac Resucitator Corp. — Product Code MKJ

K870622 is an FDA 510(k) premarket notification submitted by Cardiac Resucitator Corp. for the device "HEART*AID 1000". The FDA issued a decision of Substantially Equivalent on April 10, 1987. The device falls under product code MKJ (Automated External Defibrillators (Non-Wearable)), a Class III device regulated under 21 CFR 870.5310. Cardiac Resucitator Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1987
Date Received
February 12, 1987
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 Cardiac Resucitator Corp.

  • K882513 — MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR (July 12, 1988)
  • K871971 — MODIFIED PACE*AID MODEL 53 (June 24, 1987)
  • K871538 — STAT-PAD (TM) (June 24, 1987)
  • K871569 — MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR (June 8, 1987)
  • K850596 — PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & (March 6, 1985)
  • K850170 — HEART AID MODEL 97 (February 14, 1985)
  • K844811 — PACE AID MODEL 53 (January 24, 1985)
  • K843547 — PACE *AID MODEL 52 (December 17, 1984)
  • K843358 — HEART-AID MODEL 80 (November 19, 1984)
  • K841556 — HEART - AID ALS, 95 (July 19, 1984)

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