FDA 510(k)

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)

K-번호: K190744 · 2019-08-29

결정일2019-08-29

제품 코드HET

자문 위원회OB

결정Substantially Equivalent

기기 요약

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K190744. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)?

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K190744.

When did ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) receive FDA 510(k) clearance?

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) received FDA 510(k) clearance on 2019-08-29, under 510(k) number K190744.

Who is the listed applicant for ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)?

The FDA product code for ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) is HET.

Olympus Winter & Ibe GmbH를 신청인으로 등재한 기타 기록

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