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FDA 510(k)

NICOLET NEUROPORT/ACE SYSTEM

K-Number: K883781 · 1989-06-05

ApplicantNicolet Instrument Corp.
Decision Date1989-06-05
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NICOLET NEUROPORT/ACE 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 1989-06-05 under 510(k) number K883781. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICOLET NEUROPORT/ACE SYSTEM?

NICOLET NEUROPORT/ACE SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-05. The listed applicant is Nicolet Instrument Corp.. The 510(k) number is K883781.

When did NICOLET NEUROPORT/ACE SYSTEM receive FDA 510(k) clearance?

NICOLET NEUROPORT/ACE SYSTEM received FDA 510(k) clearance on 1989-06-05, under 510(k) number K883781.

Who is the listed applicant for NICOLET NEUROPORT/ACE 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 NEUROPORT/ACE SYSTEM?

The FDA product code for NICOLET NEUROPORT/ACE SYSTEM is IKN.

Related Clinical Trials

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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: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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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