FDA 510(k)

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe

Номер K: K213013 · 2022-09-19

Дата решения2022-09-19

Код продуктаQNQ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-09-19 under 510(k) number K213013. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe?

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is a medical device that received FDA 510(k) clearance on 2022-09-19. The listed applicant is Jeil Tech Co., Ltd.. The 510(k) number is K213013.

When did Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe receive FDA 510(k) clearance?

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe received FDA 510(k) clearance on 2022-09-19, under 510(k) number K213013.

Who is the listed applicant for Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe?

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

What is the FDA product code for Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe?

The FDA product code for Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe is QNQ.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: QNQ)

K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety SyringeCMT Health PTE., Ltd.K250127TSK SyringeTsk Laboratory, Japan K250138Small Volume 0.2mL SyringeProsum Medical Limited K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc.K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.K241190PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc.

Официальный источник

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