K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80— 510(k) K993745

Name: FDA 510(k) clearance K993745
Creator: U.S. Food and Drug Administration
Published: 2000-02-03

Substantially Equivalent

Katecho, Inc.

FDA 510(k) clearance K993745 for K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80, Substantially Equivalent on 2000-02-03. Applicant: Katecho, Inc.. Device class: 3.

Clearance details

Applicant: Katecho, Inc.
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 1999-11-05
Decision date: 2000-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Moines, IA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Katecho, Inc.

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K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-852001-10-12
K010543 — KM-30 TENS ELECTRODE2001-05-23
K003228 — K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A2000-12-14
K002806 — K-DEFIB/PACE, MODEL KDP-60A2000-11-21
K000870 — KM-10 TENS ELECTRODE2000-11-07

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.