FDA 510(k)

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

K-번호: K173384 · 2018-04-10

결정일2018-04-10

제품 코드BTO

자문 위원회AN

결정Substantially Equivalent

기기 요약

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Ads, Inc.. It received FDA 510(k) clearance on 2018-04-10 under 510(k) number K173384. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube?

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Smiths Medical Ads, Inc.. The 510(k) number is K173384.

When did BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube receive FDA 510(k) clearance?

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube received FDA 510(k) clearance on 2018-04-10, under 510(k) number K173384.

Who is the listed applicant for BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube?

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

What is the FDA product code for BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube?

The FDA product code for BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube is BTO.

Smiths Medical Ads, Inc.를 신청인으로 등재한 기타 기록

K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)

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