FDA 510(k)

Parafuso Anchor (como acessório dos Eletródos de Profundidade)

Número K: K181544 · 2018-08-09

RequerenteAd-Tech Medical Instrument Corporation

Data da decisão2018-08-09

Código do produtoGZL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anchor Bolt (as an accessory to 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 2018-08-09 under 510(k) number K181544. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anchor Bolt (as an accessory to Depth Electrodes)?

Anchor Bolt (as an accessory to Depth Electrodes) is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K181544.

When did Anchor Bolt (as an accessory to Depth Electrodes) receive FDA 510(k) clearance?

Anchor Bolt (as an accessory to Depth Electrodes) received FDA 510(k) clearance on 2018-08-09, under 510(k) number K181544.

Who is the listed applicant for Anchor Bolt (as an accessory to 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 Anchor Bolt (as an accessory to Depth Electrodes)?

The FDA product code for Anchor Bolt (as an accessory to Depth Electrodes) is GZL.

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Outros registros que listam Ad-Tech Medical Instrument Corporation como candidato(a)

K223276Parafusos de Ancore como Acessórios para Eletródes de Profundidade 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 K170442Cranial Drill Bits and Accessories K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes K152769FREMAP ELECTRODE

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: GZL)

Fonte oficial

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