FDA 510(k)

Medical Surgical Mask

N.º K: K202029 · 2020-12-16

SolicitanteBeijing Biosis Healing Biolog Ical Technology Co., Ltd.

Fecha de decisión2020-12-16

Código de productoFXX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-16 under 510(k) number K202029. 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 Medical Surgical Mask?

Medical Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-12-16. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. The 510(k) number is K202029.

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

Medical Surgical Mask received FDA 510(k) clearance on 2020-12-16, under 510(k) number K202029.

Who is the listed applicant for Medical Surgical Mask?

The FDA 510(k) record lists Beijing Biosis Healing Biolog Ical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Surgical Mask?

The FDA product code for Medical 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

Otros registros que enlistan a Beijing Biosis Healing Biolog Ical Technology Co., Ltd. como solicitante

K231513Oral Matrix K203622Medical Gloves K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads K202844Medical Surgical Gowns K201641Disposable Laparoscope Trocar K201243Disposable Specimen Retrieval Bag

Ver todos los 7 dispositivos →

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.