FDA 510(k)

EZstim*III Peripheral Nerve Stimulator/Nerve Locator

Numéro K : K162048 · 2016-12-05

Date de décision2016-12-05

Code produitKOI

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

EZstim*III Peripheral Nerve Stimulator/Nerve Locator is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health - Irvine. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K162048. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

EZstim*III Peripheral Nerve Stimulator/Nerve Locator is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Halyard Health - Irvine. The 510(k) number is K162048.

When did EZstim*III Peripheral Nerve Stimulator/Nerve Locator receive FDA 510(k) clearance?

EZstim*III Peripheral Nerve Stimulator/Nerve Locator received FDA 510(k) clearance on 2016-12-05, under 510(k) number K162048.

Who is the listed applicant for EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

The FDA 510(k) record lists Halyard Health - Irvine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

The FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator is KOI.

Essais cliniques associés

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Dispositifs connexes (Code : KOI)

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Source officielle

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