FDA 510(k)

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G

K-번호: K222111 · 2022-09-07

결정일2022-09-07

제품 코드FMK

자문 위원회SU

결정Substantially Equivalent

기기 요약

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K222111. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G?

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K222111.

When did Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G receive FDA 510(k) clearance?

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G received FDA 510(k) clearance on 2022-09-07, under 510(k) number K222111.

Who is the listed applicant for Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G?

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

What is the FDA product code for Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G?

The FDA product code for Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G is FMK.

Owen Mumford, Ltd.를 신청인으로 등재한 기타 기록

K223854Unistik® ShieldLock, Unistik VacuFlip K231124Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)K222168Unistik TinyTouch 스타일러스 싱글 유즈 헬 인셉션 세이프티 랑셋 - 프리미어와 전체 기간, Unistik Heelstik 스타일러스 싱글 유즈 헬 인셉션 세이프티 랑셋 - 마이크로 프리미어, 프리미어, 전체 기간 및 토드러 K222303Unistik® Pro K221613Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets

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