EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)— 510(k) K121628

Name: FDA 510(k) clearance K121628
Creator: U.S. Food and Drug Administration
Published: 2013-06-25

Substantially Equivalent

Epi Mobile Health Solutions (S) Pte, Ltd.

FDA 510(k) clearance K121628 for EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI), Substantially Equivalent on 2013-06-25. Applicant: Epi Mobile Health Solutions (S) Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Epi Mobile Health Solutions (S) Pte, Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2012-06-04
Decision date: 2013-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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