FDA 510(k)

Omeza Collagen Matrix

N.º K: K211972 · 2021-09-01

Fecha de decisión2021-09-01

Código de productoFRO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Omeza Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Omeza, LLC. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K211972. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Omeza Collagen Matrix?

Omeza Collagen Matrix is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Omeza, LLC. The 510(k) number is K211972.

When did Omeza Collagen Matrix receive FDA 510(k) clearance?

Omeza Collagen Matrix received FDA 510(k) clearance on 2021-09-01, under 510(k) number K211972.

Who is the listed applicant for Omeza Collagen Matrix?

The FDA 510(k) record lists Omeza, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omeza Collagen Matrix?

The FDA product code for Omeza Collagen Matrix is FRO. This falls under the Anesthesiology category.

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

Dispositivos relacionados (Código: FRO)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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.