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FDA 510(k)

BRAINET KIT

K-Number: K043009 · 2005-01-12

ApplicantJordan Neuroscience, Inc.
Decision Date2005-01-12
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAINET KIT is the device name listed in this FDA 510(k) record. The listed applicant is Jordan Neuroscience, Inc.. It received FDA 510(k) clearance on 2005-01-12 under 510(k) number K043009. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINET KIT?

BRAINET KIT is a medical device that received FDA 510(k) clearance on 2005-01-12. The listed applicant is Jordan Neuroscience, Inc.. The 510(k) number is K043009.

When did BRAINET KIT receive FDA 510(k) clearance?

BRAINET KIT received FDA 510(k) clearance on 2005-01-12, under 510(k) number K043009.

Who is the listed applicant for BRAINET KIT?

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

What is the FDA product code for BRAINET KIT?

The FDA product code for BRAINET KIT is GXY.

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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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