FDA 510(k)

EnFocus 2300, EnFocus 4400

K-번호: K162783 · 2016-12-09

결정일2016-12-09

제품 코드OBO

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

EnFocus 2300, EnFocus 4400 is the device name listed in this FDA 510(k) record. The listed applicant is Bioptigen, Inc.. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K162783. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EnFocus 2300, EnFocus 4400?

EnFocus 2300, EnFocus 4400 is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Bioptigen, Inc.. The 510(k) number is K162783.

When did EnFocus 2300, EnFocus 4400 receive FDA 510(k) clearance?

EnFocus 2300, EnFocus 4400 received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162783.

Who is the listed applicant for EnFocus 2300, EnFocus 4400?

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

What is the FDA product code for EnFocus 2300, EnFocus 4400?

The FDA product code for EnFocus 2300, EnFocus 4400 is OBO.

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EnFocus 2300, EnFocus 4400

기기 요약

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관련 임상시험

관련 기기 (코드: OBO)

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