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FDA 510(k)

NICOLET NYSTAR PLUS SYSTEM

K-Number: K884294 · 1988-11-23

ApplicantNicolet Instrument Corp.
Decision Date1988-11-23
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NICOLET NYSTAR PLUS SYSTEM 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 1988-11-23 under 510(k) number K884294. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICOLET NYSTAR PLUS SYSTEM?

NICOLET NYSTAR PLUS SYSTEM is a medical device that received FDA 510(k) clearance on 1988-11-23. The listed applicant is Nicolet Instrument Corp.. The 510(k) number is K884294.

When did NICOLET NYSTAR PLUS SYSTEM receive FDA 510(k) clearance?

NICOLET NYSTAR PLUS SYSTEM received FDA 510(k) clearance on 1988-11-23, under 510(k) number K884294.

Who is the listed applicant for NICOLET NYSTAR PLUS SYSTEM?

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 NYSTAR PLUS SYSTEM?

The FDA product code for NICOLET NYSTAR PLUS SYSTEM is GWN.

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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 SYSTEMK921927NICOLET VOYAGEURK915652NICOLET PORATBLE SPIRIT SYSTEMK905632NICOLET MAPLELEAF SYSTEMK897154NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE

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Related Devices (Code: GWN)

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.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark ApsK242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

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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