eMotion Faros ECG Mobile— 510(k) K143032

Name: FDA 510(k) clearance K143032
Creator: U.S. Food and Drug Administration
Published: 2015-03-29

Substantially Equivalent

Mega Electronics , Ltd.

FDA 510(k) clearance K143032 for eMotion Faros ECG Mobile, Substantially Equivalent on 2015-03-29. Applicant: Mega Electronics , Ltd.. Device class: 2.

Clearance details

Applicant: Mega Electronics , Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2014-10-22
Decision date: 2015-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kuopio, FI

Download summary PDF View on FDA.gov ↗

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