FDA 510(k)

오미텍 HF 절제 전극, 오미텍 HF 증발 전극

K-번호: K151976 · 2016-06-27

결정일2016-06-27

제품 코드FAS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Omnitech Systems, Inc.. It received FDA 510(k) clearance on 2016-06-27 under 510(k) number K151976. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is a medical device that received FDA 510(k) clearance on 2016-06-27. The listed applicant is Omnitech Systems, Inc.. The 510(k) number is K151976.

When did Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode receive FDA 510(k) clearance?

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode received FDA 510(k) clearance on 2016-06-27, under 510(k) number K151976.

Who is the listed applicant for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

The FDA 510(k) record lists Omnitech Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

The FDA product code for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is FAS.

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오미텍 HF 절제 전극, 오미텍 HF 증발 전극

기기 요약

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관련 임상시험

관련 기기 (코드: FAS)

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