FDA 510(k)

COMPACT AUDITORY

K-Number: K842612 · 1984-07-20

Decision Date1984-07-20

Product CodeIKN

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

COMPACT AUDITORY 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 1984-07-20 under 510(k) number K842612. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPACT AUDITORY?

COMPACT AUDITORY is a medical device that received FDA 510(k) clearance on 1984-07-20. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K842612.

When did COMPACT AUDITORY receive FDA 510(k) clearance?

COMPACT AUDITORY received FDA 510(k) clearance on 1984-07-20, under 510(k) number K842612.

Who is the listed applicant for COMPACT AUDITORY?

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 COMPACT AUDITORY?

The FDA product code for COMPACT AUDITORY is IKN.

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Other records listing Nicolet Biomedical Instruments as applicant

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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.