FIRST MEDIC MODE 610— 510(k) K883584

Name: FDA 510(k) clearance K883584
Creator: U.S. Food and Drug Administration
Published: 1988-10-06

Substantially Equivalent

First Medical Devices Corp.

FDA 510(k) clearance K883584 for FIRST MEDIC MODE 610, Substantially Equivalent on 1988-10-06. Applicant: First Medical Devices Corp.. Device class: 3.

Clearance details

Applicant: First Medical Devices Corp.
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 1988-08-22
Decision date: 1988-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from First Medical Devices Corp.

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K903657 — MODEL 610 MODIFIED1990-09-04
K895185 — FIRST MEDIC MODEL 610P1989-10-27
K880780 — HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG1988-05-12
K871135 — HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE1987-05-12
K871136 — HEARTSTART 2000, MANUAL DEFIBRILLATOR1987-05-12

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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