FDA 510(k)

FEELject LDV (Low dead volume) syringe

Número K: K213010 · 2023-05-31

Data da decisão2023-05-31

Código do produtoQNQ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

FEELject LDV (Low dead volume) syringe is the device name listed in this FDA 510(k) record. The listed applicant is Feeltech Co., Ltd.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K213010. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FEELject LDV (Low dead volume) syringe?

FEELject LDV (Low dead volume) syringe is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Feeltech Co., Ltd.. The 510(k) number is K213010.

When did FEELject LDV (Low dead volume) syringe receive FDA 510(k) clearance?

FEELject LDV (Low dead volume) syringe received FDA 510(k) clearance on 2023-05-31, under 510(k) number K213010.

Who is the listed applicant for FEELject LDV (Low dead volume) syringe?

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

What is the FDA product code for FEELject LDV (Low dead volume) syringe?

The FDA product code for FEELject LDV (Low dead volume) syringe is QNQ.

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Outros registros que listam Feeltech Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: 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.

Fonte oficial

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