FDA 510(k)

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

N.º K: K213013 · 2022-09-19

Fecha de decisión2022-09-19

Código de productoQNQ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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