FDA 510(k)

Single-Use Surgical Mask With Ear Loop

N.º K: K201691 · 2020-09-17

SolicitanteQiqihar Hengxin Medical Supplies, Ltd.

Fecha de decisión2020-09-17

Código de productoFXX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Single-Use Surgical Mask With Ear Loop is the device name listed in this FDA 510(k) record. The listed applicant is Qiqihar Hengxin Medical Supplies, Ltd.. It received FDA 510(k) clearance on 2020-09-17 under 510(k) number K201691. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Single-Use Surgical Mask With Ear Loop?

Single-Use Surgical Mask With Ear Loop is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Qiqihar Hengxin Medical Supplies, Ltd.. The 510(k) number is K201691.

When did Single-Use Surgical Mask With Ear Loop receive FDA 510(k) clearance?

Single-Use Surgical Mask With Ear Loop received FDA 510(k) clearance on 2020-09-17, under 510(k) number K201691.

Who is the listed applicant for Single-Use Surgical Mask With Ear Loop?

The FDA 510(k) record lists Qiqihar Hengxin Medical Supplies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Surgical Mask With Ear Loop?

The FDA product code for Single-Use Surgical Mask With Ear Loop is FXX.

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Otros registros que enlistan a Qiqihar Hengxin Medical Supplies, Ltd. como solicitante

K201924Single-Use Surgical Mask

Dispositivos relacionados (Código: FXX)

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Fuente oficial

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