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FDA 510(k)

MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0

K-Number: K052571 · 2005-10-17

ApplicantNeurognostics, Inc.
Decision Date2005-10-17
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Neurognostics, Inc.. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052571. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0?

MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Neurognostics, Inc.. The 510(k) number is K052571.

When did MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 receive FDA 510(k) clearance?

MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052571.

Who is the listed applicant for MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0?

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

What is the FDA product code for MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0?

The FDA product code for MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 is LNH.

Related Clinical Trials

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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Other records listing Neurognostics, Inc. as applicant

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.

K043290MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0

Related Devices (Code: LNH)

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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