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FDA 510(k)

CAREFUSION NICOLET EDX

K-Number: K120979 · 2012-04-25

ApplicantCarefusion 209, Inc.
Decision Date2012-04-25
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CAREFUSION NICOLET EDX 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 2012-04-25 under 510(k) number K120979. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAREFUSION NICOLET EDX?

CAREFUSION NICOLET EDX is a medical device that received FDA 510(k) clearance on 2012-04-25. The listed applicant is Carefusion 209, Inc.. The 510(k) number is K120979.

When did CAREFUSION NICOLET EDX receive FDA 510(k) clearance?

CAREFUSION NICOLET EDX received FDA 510(k) clearance on 2012-04-25, under 510(k) number K120979.

Who is the listed applicant for CAREFUSION NICOLET EDX?

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 CAREFUSION NICOLET EDX?

The FDA product code for CAREFUSION NICOLET EDX is GWF.

Related Clinical Trials

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.

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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.

K112052CAREFUSION NICOLET EDXK112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESK111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESK103140NICOLET WIRELESS EEG

Related Devices (Code: GWF)

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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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