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510(k) K871569

MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR by Cardiac Resucitator Corp. — Product Code DRO

K871569 is an FDA 510(k) premarket notification submitted by Cardiac Resucitator Corp. for the device "MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR". The FDA issued a decision of Substantially Equivalent on June 8, 1987. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. Cardiac Resucitator Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1987
Date Received
April 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device Class
Class II
Regulation Number
870.5550
Review Panel
CV
Submission Type

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)
  • K870622 — HEART*AID 1000 (April 10, 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 DRO

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (September 15, 1999)
  • K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (September 15, 1999)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)
  • K951593 — LIFEPAK 11 (December 29, 1995)

FDA data resources