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FDA 510(k)

SOMATOSENSORY STIMULATOR

K-Number: K810482 · 1981-04-29

ApplicantAmplaid USA, Inc.
Decision Date1981-04-29
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOMATOSENSORY STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Amplaid USA, Inc.. It received FDA 510(k) clearance on 1981-04-29 under 510(k) number K810482. 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 STIMULATOR?

SOMATOSENSORY STIMULATOR is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Amplaid USA, Inc.. The 510(k) number is K810482.

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

SOMATOSENSORY STIMULATOR received FDA 510(k) clearance on 1981-04-29, under 510(k) number K810482.

Who is the listed applicant for SOMATOSENSORY STIMULATOR?

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

What is the FDA product code for SOMATOSENSORY STIMULATOR?

The FDA product code for SOMATOSENSORY STIMULATOR is GWF.

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Other records listing Amplaid USA, 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.

K861014AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)K832510EVOKED POTENTIALS SYSTEM MK10K810473MK6 ERA SYSTEMK810481VISUAL PATTERN REVERSAL GEN. & PHOTIC S.K802963101, 151, 161 PORTABLE AUDIOMETERSK802097SELF-RECORDING ADMITTANCE METER 709

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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

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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