FDA 510(k)

Surgical Mask

N.º K: K210524 · 2021-07-07

SolicitanteChangzhou Holymed Products Co., Ltd.

Fecha de decisión2021-07-07

Código de productoFXX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Holymed Products Co., Ltd.. It received FDA 510(k) clearance on 2021-07-07 under 510(k) number K210524. 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 Surgical Mask?

Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is Changzhou Holymed Products Co., Ltd.. The 510(k) number is K210524.

When did Surgical Mask receive FDA 510(k) clearance?

Surgical Mask received FDA 510(k) clearance on 2021-07-07, under 510(k) number K210524.

Who is the listed applicant for Surgical Mask?

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

What is the FDA product code for Surgical Mask?

The FDA product code for Surgical Mask is FXX.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

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

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.