ONESTEP PEDIATRIC MFE'S— 510(k) K110978

Name: FDA 510(k) clearance K110978
Creator: U.S. Food and Drug Administration
Published: 2011-05-13

Substantially Equivalent

ZOLL Medical Corporation

FDA 510(k) clearance K110978 for ONESTEP PEDIATRIC MFE'S, Substantially Equivalent on 2011-05-13. Applicant: ZOLL Medical Corporation. Device class: 3.

Clearance details

Applicant: ZOLL Medical Corporation
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2011-04-07
Decision date: 2011-05-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Pawtucket, RI, US

Download summary PDF View on FDA.gov ↗

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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.