FDA 510(k)

Safety Insulin Syringes

N.º K: K220061 · 2022-08-23

SolicitanteBerpu Medical Technology Co., Ltd.

Fecha de decisión2022-08-23

Código de productoMEG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Safety Insulin Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K220061. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Safety Insulin Syringes?

Safety Insulin Syringes is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K220061.

When did Safety Insulin Syringes receive FDA 510(k) clearance?

Safety Insulin Syringes received FDA 510(k) clearance on 2022-08-23, under 510(k) number K220061.

Who is the listed applicant for Safety Insulin Syringes?

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

What is the FDA product code for Safety Insulin Syringes?

The FDA product code for Safety Insulin Syringes is MEG.

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Otros registros que enlistan a Berpu Medical Technology Co., Ltd. como solicitante

K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles K221045Insulin Syringes without needle K213158Syringe with permanently attached needle K213811Sterile Hypodermic Syringes for Single Use K212514Safety Pen Needle for Single Use, Insulin Pen Needles K181447Safety insulin needle for single use

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: MEG)

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med Corporation K231907Medline Safety Insulin and TB SyringesMedline Industries, LP K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

Fuente oficial

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