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FDA 510(k)

ABREU, MODEL 700

K-Number: K100843 · 2010-08-17

ApplicantBrain Tunnelgenix Technologies Corp
Decision Date2010-08-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ABREU, MODEL 700 is the device name listed in this FDA 510(k) record. The listed applicant is Brain Tunnelgenix Technologies Corp. It received FDA 510(k) clearance on 2010-08-17 under 510(k) number K100843. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABREU, MODEL 700?

ABREU, MODEL 700 is a medical device that received FDA 510(k) clearance on 2010-08-17. The listed applicant is Brain Tunnelgenix Technologies Corp. The 510(k) number is K100843.

When did ABREU, MODEL 700 receive FDA 510(k) clearance?

ABREU, MODEL 700 received FDA 510(k) clearance on 2010-08-17, under 510(k) number K100843.

Who is the listed applicant for ABREU, MODEL 700?

The FDA 510(k) record lists Brain Tunnelgenix Technologies Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABREU, MODEL 700?

The FDA product code for ABREU, MODEL 700 is FLL.

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Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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