FDA 510(k)

EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031

K-Number: K101457 · 2010-07-01

Decision Date2010-07-01

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 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 2010-07-01 under 510(k) number K101457. 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 EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031?

EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 is a medical device that received FDA 510(k) clearance on 2010-07-01. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K101457.

When did EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 receive FDA 510(k) clearance?

EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 received FDA 510(k) clearance on 2010-07-01, under 510(k) number K101457.

Who is the listed applicant for EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031?

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 EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031?

The FDA product code for EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 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.