FDA 510(k)

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

N.º K: K163355 · 2017-04-12

SolicitanteAd-Tech Medical Instrument Corporation

Fecha de decisión2017-04-12

Código de productoGZL

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes 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 2017-04-12 under 510(k) number K163355. 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 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K163355.

When did Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes receive FDA 510(k) clearance?

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes received FDA 510(k) clearance on 2017-04-12, under 510(k) number K163355.

Who is the listed applicant for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

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 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

The FDA product code for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes 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 K152769FREMAP ELECTRODE

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Fuente oficial

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