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FDA 510(k)

ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K120183 · 2012-05-11

ApplicantBroadmaster Biotech Corperation
Decision Date2012-05-11
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Broadmaster Biotech Corperation. It received FDA 510(k) clearance on 2012-05-11 under 510(k) number K120183. 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 ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM?

ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-11. The listed applicant is Broadmaster Biotech Corperation. The 510(k) number is K120183.

When did ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2012-05-11, under 510(k) number K120183.

Who is the listed applicant for ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM?

The FDA 510(k) record lists Broadmaster Biotech Corperation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

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Official Source

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