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510(k) K880780

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG by First Medical Devices Corp. — Product Code DRL

K880780 is an FDA 510(k) premarket notification submitted by First Medical Devices Corp. for the device "HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG". The FDA issued a decision of Substantially Equivalent on May 12, 1988. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. First Medical Devices Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1988
Date Received
February 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Defibrillator
Device Class
Class II
Regulation Number
870.5325
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)
  • K871136 — HEARTSTART 2000, MANUAL DEFIBRILLATOR (May 12, 1987)
  • K871135 — HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE (May 12, 1987)
  • K860676 — HEARTSTART 2000 (April 30, 1986)

Other clearances for product code DRL

  • K190437 — Delta 3300 (August 28, 2019)
  • K182905 — UniPulse (December 14, 2018)
  • K153210 — Defibrillator Analyzer Variable Load (December 21, 2015)
  • K110192 — DEFIBRILLATOR ANALYZER - DA-2006P (February 8, 2011)
  • K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (December 24, 2008)
  • K072114 — IMPULSE 6000D/7000DP (January 28, 2008)
  • K062099 — PHASE 3, MODEL DT-1 (January 25, 2007)
  • K030547 — MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (July 11, 2003)
  • K963190 — QA-40M DEFIBRILLATOR TESTER (July 1, 1997)
  • K961595 — DEFIBRILLATOR ANALYZER, DELTA 1000 (October 29, 1996)

FDA data resources