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FDA 510(k)

ENVOYCEM, MODEL 1640

K-Number: K080032 · 2008-02-28

ApplicantEnvoy Medical Corporation
Decision Date2008-02-28
Product CodeNEA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENVOYCEM, MODEL 1640 is the device name listed in this FDA 510(k) record. The listed applicant is Envoy Medical Corporation. It received FDA 510(k) clearance on 2008-02-28 under 510(k) number K080032. The device is classified under product code NEA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENVOYCEM, MODEL 1640?

ENVOYCEM, MODEL 1640 is a medical device that received FDA 510(k) clearance on 2008-02-28. The listed applicant is Envoy Medical Corporation. The 510(k) number is K080032.

When did ENVOYCEM, MODEL 1640 receive FDA 510(k) clearance?

ENVOYCEM, MODEL 1640 received FDA 510(k) clearance on 2008-02-28, under 510(k) number K080032.

Who is the listed applicant for ENVOYCEM, MODEL 1640?

The FDA 510(k) record lists Envoy Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENVOYCEM, MODEL 1640?

The FDA product code for ENVOYCEM, MODEL 1640 is NEA.

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Related Devices (Code: NEA)

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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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