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FDA 510(k)

RESNICK EMITTER, ARTIFICIAL LARYNX

K-Number: K854158 · 1985-12-13

ApplicantDynamed Audio, Inc.
Decision Date1985-12-13
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RESNICK EMITTER, ARTIFICIAL LARYNX is the device name listed in this FDA 510(k) record. The listed applicant is Dynamed Audio, Inc.. It received FDA 510(k) clearance on 1985-12-13 under 510(k) number K854158. The device is classified under product code ESE. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESNICK EMITTER, ARTIFICIAL LARYNX?

RESNICK EMITTER, ARTIFICIAL LARYNX is a medical device that received FDA 510(k) clearance on 1985-12-13. The listed applicant is Dynamed Audio, Inc.. The 510(k) number is K854158.

When did RESNICK EMITTER, ARTIFICIAL LARYNX receive FDA 510(k) clearance?

RESNICK EMITTER, ARTIFICIAL LARYNX received FDA 510(k) clearance on 1985-12-13, under 510(k) number K854158.

Who is the listed applicant for RESNICK EMITTER, ARTIFICIAL LARYNX?

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

What is the FDA product code for RESNICK EMITTER, ARTIFICIAL LARYNX?

The FDA product code for RESNICK EMITTER, ARTIFICIAL LARYNX is ESE.

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Related Devices (Code: ESE)

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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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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