FDA 510(k)

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)

K-번호: K171505 · 2018-05-17

결정일2018-05-17

제품 코드FIE

자문 위원회GU

결정Substantially Equivalent

기기 요약

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) is the device name listed in this FDA 510(k) record. The listed applicant is Dimesol, Inc.. It received FDA 510(k) clearance on 2018-05-17 under 510(k) number K171505. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)?

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) is a medical device that received FDA 510(k) clearance on 2018-05-17. The listed applicant is Dimesol, Inc.. The 510(k) number is K171505.

When did Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) receive FDA 510(k) clearance?

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) received FDA 510(k) clearance on 2018-05-17, under 510(k) number K171505.

Who is the listed applicant for Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)?

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

What is the FDA product code for Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)?

The FDA product code for Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) is FIE.

Dimesol, Inc.를 신청인으로 등재한 기타 기록

K171952Dimesol Tubing Sets for Hemodialysis

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