EMOTION ECG MOBILE— 510(k) K131699

Substantially Equivalent

Mega Electronics , Ltd.

FDA 510(k) clearance K131699 for EMOTION ECG MOBILE, Substantially Equivalent on 2013-11-26. 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: 2013-06-11
Decision date: 2013-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Hague, NL

Download summary PDF View on FDA.gov ↗

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