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FDA 510(k)

EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM

K-Number: K113243 · 2012-03-28

ApplicantEps Bio Technology Corp.
Decision Date2012-03-28
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eps Bio Technology Corp.. It received FDA 510(k) clearance on 2012-03-28 under 510(k) number K113243. The device is classified under product code LFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM?

EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-28. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K113243.

When did EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM receive FDA 510(k) clearance?

EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM received FDA 510(k) clearance on 2012-03-28, under 510(k) number K113243.

Who is the listed applicant for EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM?

The FDA 510(k) record lists Eps Bio Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM?

The FDA product code for EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM is LFR.

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Other records listing Eps Bio Technology Corp. 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.

K201258EASYMAX Tag Self-Monitoring Blood Glucose SystemK190189MDT2 BLE Self-Monitoring Blood Glucose SystemK182057EasyMax BT Self-Monitoring Blood Glucose SystemK121207EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEMK112901EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEMK111728EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

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Related Devices (Code: LFR)

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.

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical CorporationK121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical CorporationK113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation

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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