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FDA 510(k)

SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION

K-Number: K130346 · 2013-05-02

ApplicantNatus Neurology Incorporated
Decision Date2013-05-02
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION is the device name listed in this FDA 510(k) record. The listed applicant is Natus Neurology Incorporated. It received FDA 510(k) clearance on 2013-05-02 under 510(k) number K130346. 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 SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION?

SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION is a medical device that received FDA 510(k) clearance on 2013-05-02. The listed applicant is Natus Neurology Incorporated. The 510(k) number is K130346.

When did SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION receive FDA 510(k) clearance?

SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION received FDA 510(k) clearance on 2013-05-02, under 510(k) number K130346.

Who is the listed applicant for SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION?

The FDA 510(k) record lists Natus Neurology Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION?

The FDA product code for SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION is GWF.

Related Clinical Trials

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Other records listing Natus Neurology Incorporated 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.

K243982Nicolet EDXK243495Natus Ultrapro S100 (982A0594)K173366NicoletOneK172743Natus VikingQuest

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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