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FDA 510(k)

BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE

K-Number: K990538 · 1999-05-19

ApplicantBrainmaster
Decision Date1999-05-19
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Brainmaster. It received FDA 510(k) clearance on 1999-05-19 under 510(k) number K990538. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE?

BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE is a medical device that received FDA 510(k) clearance on 1999-05-19. The listed applicant is Brainmaster. The 510(k) number is K990538.

When did BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE receive FDA 510(k) clearance?

BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE received FDA 510(k) clearance on 1999-05-19, under 510(k) number K990538.

Who is the listed applicant for BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE?

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

What is the FDA product code for BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE?

The FDA product code for BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE is HCC.

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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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