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FDA 510(k)

NICOLET WIRELESS EEG

K-Number: K103140 · 2011-04-08

ApplicantCarefusion 209, Inc.
Decision Date2011-04-08
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NICOLET WIRELESS EEG is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 209, Inc.. It received FDA 510(k) clearance on 2011-04-08 under 510(k) number K103140. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICOLET WIRELESS EEG?

NICOLET WIRELESS EEG is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Carefusion 209, Inc.. The 510(k) number is K103140.

When did NICOLET WIRELESS EEG receive FDA 510(k) clearance?

NICOLET WIRELESS EEG received FDA 510(k) clearance on 2011-04-08, under 510(k) number K103140.

Who is the listed applicant for NICOLET WIRELESS EEG?

The FDA 510(k) record lists Carefusion 209, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NICOLET WIRELESS EEG?

The FDA product code for NICOLET WIRELESS EEG is GWL.

Related Clinical Trials

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Other records listing Carefusion 209, Inc. 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.

K120979CAREFUSION NICOLET EDXK112052CAREFUSION NICOLET EDXK112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESK111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES

Related Devices (Code: GWL)

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.

K243746Delphi AmplifierQuantalx NeroscienceK242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS RemwareK232210X-trodes System MX-TrodesK230148VlabDormotech Medical, Ltd.

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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