FDA 510(k)

DNAP Electrode

N.º K: K152547 · 2016-03-04

SolicitanteAd-Tech Medical Instrument Corporation

Fecha de decisión2016-03-04

Código de productoGZL

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

DNAP Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K152547. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DNAP Electrode?

DNAP Electrode is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K152547.

When did DNAP Electrode receive FDA 510(k) clearance?

DNAP Electrode received FDA 510(k) clearance on 2016-03-04, under 510(k) number K152547.

Who is the listed applicant for DNAP Electrode?

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

What is the FDA product code for DNAP Electrode?

The FDA product code for DNAP Electrode is GZL.

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Otros registros que enlistan a Ad-Tech Medical Instrument Corporation como solicitante

K223276Bujones Anchor como Accesorios de Electrodos de Profundidad K223269Spencer Probe Depth Electrodes K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode K181544Anchor Bolt (como accesorio de Electrodos de Profundidad)K170442Cranial Drill Bits and Accessories K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

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Fuente oficial

Ver en la base de datos de la FDA →

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