FDA 510(k)

INSERT EARPHONES

K-Number: K862363 · 1986-09-17

Decision Date1986-09-17

Product CodeGWJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

INSERT EARPHONES is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1986-09-17 under 510(k) number K862363. 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 INSERT EARPHONES?

INSERT EARPHONES is a medical device that received FDA 510(k) clearance on 1986-09-17. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K862363.

When did INSERT EARPHONES receive FDA 510(k) clearance?

INSERT EARPHONES received FDA 510(k) clearance on 1986-09-17, under 510(k) number K862363.

Who is the listed applicant for INSERT EARPHONES?

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

What is the FDA product code for INSERT EARPHONES?

The FDA product code for INSERT EARPHONES is 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.