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FDA 510(k)

NICOLET VOYAGEUR

K-Number: K921927 · 1992-11-05

ApplicantNicolet Instrument Corp.
Decision Date1992-11-05
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NICOLET VOYAGEUR is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Instrument Corp.. It received FDA 510(k) clearance on 1992-11-05 under 510(k) number K921927. 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 VOYAGEUR?

NICOLET VOYAGEUR is a medical device that received FDA 510(k) clearance on 1992-11-05. The listed applicant is Nicolet Instrument Corp.. The 510(k) number is K921927.

When did NICOLET VOYAGEUR receive FDA 510(k) clearance?

NICOLET VOYAGEUR received FDA 510(k) clearance on 1992-11-05, under 510(k) number K921927.

Who is the listed applicant for NICOLET VOYAGEUR?

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

What is the FDA product code for NICOLET VOYAGEUR?

The FDA product code for NICOLET VOYAGEUR is GWQ.

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Other records listing Nicolet Instrument Corp. 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.

K921138NICOLET ULTRASOM ACQUISITION STATIONK923315NICOLET ARK SYSTEMK915652NICOLET PORATBLE SPIRIT SYSTEMK905632NICOLET MAPLELEAF SYSTEMK897154NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLEK894629NICOLET BEAM II SYSTEM

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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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