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FDA 510(k)

PATHFINDER ELECTRODIAGNOSTIC SYSTEM

K-Number: K801604 · 1980-08-04

ApplicantNicolet Biomedical Instruments
Decision Date1980-08-04
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PATHFINDER ELECTRODIAGNOSTIC SYSTEM 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 1980-08-04 under 510(k) number K801604. 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 PATHFINDER ELECTRODIAGNOSTIC SYSTEM?

PATHFINDER ELECTRODIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K801604.

When did PATHFINDER ELECTRODIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

PATHFINDER ELECTRODIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801604.

Who is the listed applicant for PATHFINDER ELECTRODIAGNOSTIC SYSTEM?

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 PATHFINDER ELECTRODIAGNOSTIC SYSTEM?

The FDA product code for PATHFINDER ELECTRODIAGNOSTIC SYSTEM 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.

K060919ACTICALRespironics, Inc.K061870VITALSENSE XHRRespironics, Inc.K052489ACTIHEARTRespironics, Inc.K991045MINI-LOGGER SERIES 2000Mini-Mitter Co., Inc.K905594NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300Nihon Kohden America, Inc.K904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMTelediagnostic Systems, Inc.

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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