ImPACT — 510(k) de la FDA K170209

Resumen del dispositivo

ImPACT is the device name listed in this FDA 510(k) record. The listed applicant is Impact Applications, Inc.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K170209. The device is classified under product code POM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ImPACT?

ImPACT is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Impact Applications, Inc.. The 510(k) number is K170209.

When did ImPACT receive FDA 510(k) clearance?

ImPACT received FDA 510(k) clearance on 2017-02-23, under 510(k) number K170209.

Who is the listed applicant for ImPACT?

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

What is the FDA product code for ImPACT?

The FDA product code for ImPACT is POM.

Ensayos clínicos relacionados

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Literatura relacionada en PubMed

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.

PMID: 42106561Impact1: Supporting Innovation in Pediatric and Maternal Health-5 Years of Outcomes.Annals of biomedical engineering ()PMID: 40498444Assessing the Impact of End-of-Life Processing on Reusable Medical Devices.Biomedical instrumentation & technology ()PMID: 39081796Recent Advances in the Design and Application of Shoulder Arthroplasty Implant Systems and Their Impact on Clinical Outcomes: A Comprehensive Review.Orthopedic research and reviews ()PMID: 37579360Impact of the Regulatory Framework on Medical Device Software Manufacturers: Are the Guidance Documents Supporting the Practical Implementation? Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".International journal of health policy and management ()

Otros registros que enlistan a Impact Applications, Inc. como solicitante

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.

K231688ImPACT Version 4 K202485ImPACT Version 4 K181223ImPACT K170551ImPACT Quick Test

Dispositivos relacionados (Código: POM)

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.

K241737Sway System Sports PlusSway Medical, Inc.K231688ImPACT Version 4Impact Applications, Inc.K201376Sistema de Pruebas ANAMVista Lifesciences, Inc.K202485ImPACT Version 4Impact Applications, Inc.K181223ImPACTImpact Applications, Inc.K170551ImPACT Quick TestImpact Applications, Inc.

Fuente oficial

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