TESLA GUARD, MODEL EFT G04— 510(k) K071802

Name: FDA 510(k) clearance K071802
Creator: U.S. Food and Drug Administration
Published: 2007-11-09

Substantially Equivalent

Mammendorfer Institut Fur Physik Und Medizin GmbH

FDA 510(k) clearance K071802 for TESLA GUARD, MODEL EFT G04, Substantially Equivalent on 2007-11-09. Applicant: Mammendorfer Institut Fur Physik Und Medizin GmbH. Device class: 2.

Clearance details

Applicant: Mammendorfer Institut Fur Physik Und Medizin GmbH
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2007-07-02
Decision date: 2007-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.