FDA 510(k)

EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K011240 · 2001-09-13

Decision Date2001-09-13

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EVENCARE BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2001-09-13 under 510(k) number K011240. 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 EVENCARE BLOOD GLUCOSE MONITORING SYSTEM?

EVENCARE BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-13. The listed applicant is Medline Industries, Inc.. The 510(k) number is K011240.

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

EVENCARE BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2001-09-13, under 510(k) number K011240.

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

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

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

The FDA product code for EVENCARE 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.