Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

SURGICAL MASK, Model Name:C015

N.º K: K210218 · 2021-05-07

SolicitanteQingdao Hainuo Biological Engineering Co., Ltd.
Fecha de decisión2021-05-07
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

SURGICAL MASK, Model Name:C015 is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hainuo Biological Engineering Co., Ltd.. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K210218. 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, Model Name:C015?

SURGICAL MASK, Model Name:C015 is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Qingdao Hainuo Biological Engineering Co., Ltd.. The 510(k) number is K210218.

When did SURGICAL MASK, Model Name:C015 receive FDA 510(k) clearance?

SURGICAL MASK, Model Name:C015 received FDA 510(k) clearance on 2021-05-07, under 510(k) number K210218.

Who is the listed applicant for SURGICAL MASK, Model Name:C015?

The FDA 510(k) record lists Qingdao Hainuo Biological Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL MASK, Model Name:C015?

The FDA product code for SURGICAL MASK, Model Name:C015 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: FXX)

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.

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.

↑