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FDA 510(k)

NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM

K-Number: K873535 · 1987-10-26

ApplicantNicolet Biomedical Instruments
Decision Date1987-10-26
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NICOLET EXPERT SLEEP/WAKE ANALYSIS 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 1987-10-26 under 510(k) number K873535. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM?

NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1987-10-26. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K873535.

When did NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM receive FDA 510(k) clearance?

NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM received FDA 510(k) clearance on 1987-10-26, under 510(k) number K873535.

Who is the listed applicant for NICOLET EXPERT SLEEP/WAKE ANALYSIS 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 NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM?

The FDA product code for NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM is GWQ.

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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 PROBEK871678NICOLET AMP 6R11 SYSTEMK862592PHOENIX SYSTEM SEVEN.K851190NYSTAGMOGRAPH EOG/ENG ANALYSES

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Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, 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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