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510(k) K871135

HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE by First Medical Devices Corp. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1987
Date Received
March 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type

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)
  • K860676 — HEARTSTART 2000 (April 30, 1986)

Other clearances for product code LDD

  • K203231 — Switched Internal Paddles (January 11, 2021)
  • K200849 — Tempus LS - Manual (July 24, 2020)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K150349 — Rapid Hair Removal Pads (July 14, 2015)
  • K140502 — ZOLL E SERIES ALS (November 6, 2014)
  • K103651 — CARDIOMED (October 4, 2011)
  • K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI (June 16, 2011)
  • K103334 — CARDIO MED (January 18, 2011)
  • K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (January 11, 2011)
  • K102468 — ZOLL PROPAQ MD (September 30, 2010)