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FDA 510(k)

INVOTEC LARYNGEAL ELECTRODE

K-Number: K122040 · 2013-10-31

ApplicantInvotec International, Inc.
Decision Date2013-10-31
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INVOTEC LARYNGEAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Invotec International, Inc.. It received FDA 510(k) clearance on 2013-10-31 under 510(k) number K122040. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVOTEC LARYNGEAL ELECTRODE?

INVOTEC LARYNGEAL ELECTRODE is a medical device that received FDA 510(k) clearance on 2013-10-31. The listed applicant is Invotec International, Inc.. The 510(k) number is K122040.

When did INVOTEC LARYNGEAL ELECTRODE receive FDA 510(k) clearance?

INVOTEC LARYNGEAL ELECTRODE received FDA 510(k) clearance on 2013-10-31, under 510(k) number K122040.

Who is the listed applicant for INVOTEC LARYNGEAL ELECTRODE?

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

What is the FDA product code for INVOTEC LARYNGEAL ELECTRODE?

The FDA product code for INVOTEC LARYNGEAL ELECTRODE is ETN.

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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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