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FDA 510(k)

BRAIN FUNCTION MAPPING OPTION FOR PATHF

K-Number: K843598 · 1985-04-11

ApplicantNicolet Biomedical Instruments
Decision Date1985-04-11
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRAIN FUNCTION MAPPING OPTION FOR PATHF is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical Instruments. It received FDA 510(k) clearance on 1985-04-11 under 510(k) number K843598. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAIN FUNCTION MAPPING OPTION FOR PATHF?

BRAIN FUNCTION MAPPING OPTION FOR PATHF is a medical device that received FDA 510(k) clearance on 1985-04-11. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K843598.

When did BRAIN FUNCTION MAPPING OPTION FOR PATHF receive FDA 510(k) clearance?

BRAIN FUNCTION MAPPING OPTION FOR PATHF received FDA 510(k) clearance on 1985-04-11, under 510(k) number K843598.

Who is the listed applicant for BRAIN FUNCTION MAPPING OPTION FOR PATHF?

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

What is the FDA product code for BRAIN FUNCTION MAPPING OPTION FOR PATHF?

The FDA product code for BRAIN FUNCTION MAPPING OPTION FOR PATHF is GWK.

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Other records listing Nicolet Biomedical Instruments 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.

K880573MODIFIED NICOLET VIKING SYSTEMK873736NICOLET DIGITAL TWO PIECE HEARING AIDK873964NICOLET DISPOSABLE PRASS PROBEK873535NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEMK871678NICOLET AMP 6R11 SYSTEMK862592PHOENIX SYSTEM SEVEN.

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Related Devices (Code: GWK)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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