FDA 510(k)

AccuPoint 전극

K-번호: K162459 · 2017-06-15

신청자Microprobes For Life Science, Inc. Dba Neuron

결정일2017-06-15

제품 코드GZL

자문 위원회NE

결정Substantially Equivalent

기기 요약

AccuPoint Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Microprobes For Life Science, Inc. Dba Neuron. It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K162459. 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 AccuPoint Electrode?

AccuPoint Electrode is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Microprobes For Life Science, Inc. Dba Neuron. The 510(k) number is K162459.

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

AccuPoint Electrode received FDA 510(k) clearance on 2017-06-15, under 510(k) number K162459.

Who is the listed applicant for AccuPoint Electrode?

The FDA 510(k) record lists Microprobes For Life Science, Inc. Dba Neuron as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccuPoint Electrode?

The FDA product code for AccuPoint Electrode is GZL.

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