ECG HOME— 510(k) K012012

Substantially Equivalent

H&C Medical Devices Spa

FDA 510(k) clearance K012012 for ECG HOME, Substantially Equivalent on 2002-01-17. Applicant: H&C Medical Devices Spa. Device class: 2.

Clearance details

Applicant: H&C Medical Devices Spa
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2001-06-28
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sesto San Giovanni, IT

Download summary PDF View on FDA.gov ↗

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