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FDA 510(k)

MULTI-SIGNAL AUDITORY STIMULATOR SM700

K-Number: K830579 · 1983-03-08

ApplicantNicolet Biomedical Instruments
Decision Date1983-03-08
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MULTI-SIGNAL AUDITORY STIMULATOR SM700 is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical Instruments. It received FDA 510(k) clearance on 1983-03-08 under 510(k) number K830579. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI-SIGNAL AUDITORY STIMULATOR SM700?

MULTI-SIGNAL AUDITORY STIMULATOR SM700 is a medical device that received FDA 510(k) clearance on 1983-03-08. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K830579.

When did MULTI-SIGNAL AUDITORY STIMULATOR SM700 receive FDA 510(k) clearance?

MULTI-SIGNAL AUDITORY STIMULATOR SM700 received FDA 510(k) clearance on 1983-03-08, under 510(k) number K830579.

Who is the listed applicant for MULTI-SIGNAL AUDITORY STIMULATOR SM700?

The FDA 510(k) record lists Nicolet Biomedical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTI-SIGNAL AUDITORY STIMULATOR SM700?

The FDA product code for MULTI-SIGNAL AUDITORY STIMULATOR SM700 is GWJ.

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Other records listing Nicolet Biomedical Instruments 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.

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Related Devices (Code: GWJ)

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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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