FDA 510(k)

EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008

K-Number: K083099 · 2009-01-16

Decision Date2009-01-16

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 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 2009-01-16 under 510(k) number K083099. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008?

EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 is a medical device that received FDA 510(k) clearance on 2009-01-16. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K083099.

When did EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 receive FDA 510(k) clearance?

EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 received FDA 510(k) clearance on 2009-01-16, under 510(k) number K083099.

Who is the listed applicant for EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008?

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 EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008?

The FDA product code for EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 is NBW. This falls under the OB/GYN category.

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Official Source

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