FDA 510(k)

EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017

K-Number: K101037 · 2011-05-23

Decision Date2011-05-23

Product CodeLFR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 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 2011-05-23 under 510(k) number K101037. 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 EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017?

EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 is a medical device that received FDA 510(k) clearance on 2011-05-23. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K101037.

When did EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 receive FDA 510(k) clearance?

EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 received FDA 510(k) clearance on 2011-05-23, under 510(k) number K101037.

Who is the listed applicant for EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017?

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 EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017?

The FDA product code for EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 is LFR.

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Related Devices (Code: LFR)

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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.