POWERCHARGER— 510(k) K934016

Name: FDA 510(k) clearance K934016
Creator: U.S. Food and Drug Administration
Published: 1994-10-18

Substantially Equivalent

Zoll Medical Corp

FDA 510(k) clearance K934016 for POWERCHARGER, Substantially Equivalent on 1994-10-18. Applicant: Zoll Medical Corp. Device class: 2.

Clearance details

Applicant: Zoll Medical Corp
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 1993-08-18
Decision date: 1994-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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K042007 — ZOLL E SERIES DEFIBRILLATOR2005-04-07
K042302 — ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE2004-10-26

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.