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FDA 510(k)

EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)

K-Number: K121628 · 2013-06-25

ApplicantEpi Mobile Health Solutions (S) Pte, Ltd.
Decision Date2013-06-25
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) is the device name listed in this FDA 510(k) record. The listed applicant is Epi Mobile Health Solutions (S) Pte, Ltd.. It received FDA 510(k) clearance on 2013-06-25 under 510(k) number K121628. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)?

EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) is a medical device that received FDA 510(k) clearance on 2013-06-25. The listed applicant is Epi Mobile Health Solutions (S) Pte, Ltd.. The 510(k) number is K121628.

When did EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) receive FDA 510(k) clearance?

EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) received FDA 510(k) clearance on 2013-06-25, under 510(k) number K121628.

Who is the listed applicant for EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)?

The FDA 510(k) record lists Epi Mobile Health Solutions (S) Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)?

The FDA product code for EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) is DXH. This falls under the Hematology category.

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Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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