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FDA 510(k)

EASYMATE BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K053312 · 2006-03-01

ApplicantBioptik Technology, Inc.
Decision Date2006-03-01
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYMATE BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bioptik Technology, Inc.. It received FDA 510(k) clearance on 2006-03-01 under 510(k) number K053312. 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 EASYMATE BLOOD GLUCOSE MONITORING SYSTEM?

EASYMATE BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-01. The listed applicant is Bioptik Technology, Inc.. The 510(k) number is K053312.

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

EASYMATE BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2006-03-01, under 510(k) number K053312.

Who is the listed applicant for EASYMATE BLOOD GLUCOSE MONITORING SYSTEM?

The FDA 510(k) record lists Bioptik Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for EASYMATE BLOOD GLUCOSE MONITORING SYSTEM 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.

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