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FDA 510(k)

NICOLET BRAINLAB SYSTEM

K-Number: K882599 · 1988-10-19

ApplicantNicolet Instrument Corp.
Decision Date1988-10-19
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NICOLET BRAINLAB 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 1988-10-19 under 510(k) number K882599. 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 NICOLET BRAINLAB SYSTEM?

NICOLET BRAINLAB SYSTEM is a medical device that received FDA 510(k) clearance on 1988-10-19. The listed applicant is Nicolet Instrument Corp.. The 510(k) number is K882599.

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

NICOLET BRAINLAB SYSTEM received FDA 510(k) clearance on 1988-10-19, under 510(k) number K882599.

Who is the listed applicant for NICOLET BRAINLAB 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 BRAINLAB SYSTEM?

The FDA product code for NICOLET BRAINLAB SYSTEM is GWK.

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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: 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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