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FDA 510(k)

EMOTION ECG MOBILE

K-Number: K131699 · 2013-11-26

ApplicantMega Electronics , Ltd.
Decision Date2013-11-26
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMOTION ECG MOBILE is the device name listed in this FDA 510(k) record. The listed applicant is Mega Electronics , Ltd.. It received FDA 510(k) clearance on 2013-11-26 under 510(k) number K131699. 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 EMOTION ECG MOBILE?

EMOTION ECG MOBILE is a medical device that received FDA 510(k) clearance on 2013-11-26. The listed applicant is Mega Electronics , Ltd.. The 510(k) number is K131699.

When did EMOTION ECG MOBILE receive FDA 510(k) clearance?

EMOTION ECG MOBILE received FDA 510(k) clearance on 2013-11-26, under 510(k) number K131699.

Who is the listed applicant for EMOTION ECG MOBILE?

The FDA 510(k) record lists Mega Electronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMOTION ECG MOBILE?

The FDA product code for EMOTION ECG MOBILE is DXH. This falls under the Hematology category.

Related Clinical Trials

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Other records listing Mega Electronics , Ltd. as applicant

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.

K993411FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTRK963202MEGA ME 3000 PROFESSIONAL MUSCLE TESTER

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.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

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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