FDA 510(k)

PRIMED Pediatric Facemask

N.º K: K213427 · 2022-11-22

SolicitantePrimed Medical Products, Inc.

Fecha de decisión2022-11-22

Código de productoOXZ

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PRIMED Pediatric Facemask is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K213427. 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 PRIMED Pediatric Facemask?

PRIMED Pediatric Facemask is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K213427.

When did PRIMED Pediatric Facemask receive FDA 510(k) clearance?

PRIMED Pediatric Facemask received FDA 510(k) clearance on 2022-11-22, under 510(k) number K213427.

Who is the listed applicant for PRIMED Pediatric Facemask?

The FDA 510(k) record lists Primed Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMED Pediatric Facemask?

The FDA product code for PRIMED Pediatric Facemask 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 Primed Medical Products, Inc. como solicitante

K262007PRIMED AAMI Level 3 Open Back Gowns K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)K252964PRIMED Surgical and Procedure Masks K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K240286PRIMED Surgical Masks and PRIMED Procedure Masks K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: OXZ)

K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.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.