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)

Cross Protection ResQ300 Plus Surgical Face Mask

N.º K: K212273 · 2022-08-17

SolicitanteCross Protection (M) Sdn Bhd
Fecha de decisión2022-08-17
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Cross Protection ResQ300 Plus Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Cross Protection (M) Sdn Bhd. It received FDA 510(k) clearance on 2022-08-17 under 510(k) number K212273. 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 Cross Protection ResQ300 Plus Surgical Face Mask?

Cross Protection ResQ300 Plus Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2022-08-17. The listed applicant is Cross Protection (M) Sdn Bhd. The 510(k) number is K212273.

When did Cross Protection ResQ300 Plus Surgical Face Mask receive FDA 510(k) clearance?

Cross Protection ResQ300 Plus Surgical Face Mask received FDA 510(k) clearance on 2022-08-17, under 510(k) number K212273.

Who is the listed applicant for Cross Protection ResQ300 Plus Surgical Face Mask?

The FDA 510(k) record lists Cross Protection (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cross Protection ResQ300 Plus Surgical Face Mask?

The FDA product code for Cross Protection ResQ300 Plus Surgical Face 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_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.

↑