FDA 510(k)

Kangbeier Child Surgical Mask

N.º K: K221753 · 2023-12-21

SolicitanteXinxiang Kangbeier Medical Technology Co., Ltd.

Fecha de decisión2023-12-21

Código de productoOXZ

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Kangbeier Child Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Xinxiang Kangbeier Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K221753. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Kangbeier Child Surgical Mask?

Kangbeier Child Surgical Mask is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Xinxiang Kangbeier Medical Technology Co., Ltd.. The 510(k) number is K221753.

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

Kangbeier Child Surgical Mask received FDA 510(k) clearance on 2023-12-21, under 510(k) number K221753.

Who is the listed applicant for Kangbeier Child Surgical Mask?

The FDA 510(k) record lists Xinxiang Kangbeier Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kangbeier Child Surgical Mask?

The FDA product code for Kangbeier Child Surgical Mask is OXZ.

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 Xinxiang Kangbeier Medical Technology Co., Ltd. como solicitante

K213920Kangbeier Surgical Mask (Model: KBR-1001)

Dispositivos relacionados (Código: OXZ)

K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation K201514Child Face MaskShandong Shengquan New Material Co., Ltd.K202831The iMask Child's Face MaskPac-Dent, Inc.K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)Amd Medicom, Inc.K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech

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.