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FDA 510(k)

SOMATOSENSORY EVOKED POTENTIAL STIMULATOR

K-Number: K855232 · 1986-07-03

ApplicantNeuroscience, Inc.
Decision Date1986-07-03
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOMATOSENSORY EVOKED POTENTIAL STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Neuroscience, Inc.. It received FDA 510(k) clearance on 1986-07-03 under 510(k) number K855232. 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 SOMATOSENSORY EVOKED POTENTIAL STIMULATOR?

SOMATOSENSORY EVOKED POTENTIAL STIMULATOR is a medical device that received FDA 510(k) clearance on 1986-07-03. The listed applicant is Neuroscience, Inc.. The 510(k) number is K855232.

When did SOMATOSENSORY EVOKED POTENTIAL STIMULATOR receive FDA 510(k) clearance?

SOMATOSENSORY EVOKED POTENTIAL STIMULATOR received FDA 510(k) clearance on 1986-07-03, under 510(k) number K855232.

Who is the listed applicant for SOMATOSENSORY EVOKED POTENTIAL STIMULATOR?

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

What is the FDA product code for SOMATOSENSORY EVOKED POTENTIAL STIMULATOR?

The FDA product code for SOMATOSENSORY EVOKED POTENTIAL STIMULATOR is GWF.

Related Clinical Trials

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Other records listing Neuroscience, 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.

K871931ISTAT SOFTWAREK870263NEUROMAPPER 1620K850430NEUROSCIENCE MAP-10 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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