FDA 510(k)

깊이 전극, 원형공 깊이 전극, 마코-마이크로 깊이 전극, 스펜서探头 깊이 전극

K-번호: K163355 · 2017-04-12

신청자Ad-Tech Medical Instrument Corporation

결정일2017-04-12

제품 코드GZL

자문 위원회NE

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Ad-Tech Medical Instrument Corporation를 신청인으로 등재한 기타 기록

K223276Depth Electrodes의 부속품으로 Anchor Bolts 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 (Depth Electrodes의 부속품으로)K170442뇌 drill 비트 및 액세서리 K152769FREMAP ELECTRODE

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