HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG— 510(k) K880780

Name: FDA 510(k) clearance K880780
Creator: U.S. Food and Drug Administration
Published: 1988-05-12

Substantially Equivalent

First Medical Devices Corp.

FDA 510(k) clearance K880780 for HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG, Substantially Equivalent on 1988-05-12. Applicant: First Medical Devices Corp.. Device class: 2.

Clearance details

Applicant: First Medical Devices Corp.
Product code: Code DRL
Device class: Class 2
Regulation: 21 CFR 870.5325
Advisory panel: Cardiovascular
Date received: 1988-02-26
Decision date: 1988-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRL

view all

K190437 — Delta 33002019-08-28
K182905 — UniPulse2018-12-14
K153210 — Defibrillator Analyzer Variable Load2015-12-21
K110192 — DEFIBRILLATOR ANALYZER - DA-2006P2011-02-08
K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS2008-12-24

More clearances from First Medical Devices Corp.

view all

K903657 — MODEL 610 MODIFIED1990-09-04
K895185 — FIRST MEDIC MODEL 610P1989-10-27
K883584 — FIRST MEDIC MODE 6101988-10-06
K871135 — HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE1987-05-12
K871136 — HEARTSTART 2000, MANUAL DEFIBRILLATOR1987-05-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.