FDA 510(k)

Medline Anti-Fog Solution

Número K: K152948 · 2016-02-04

Data da decisão2016-02-04

Código do produtoOCT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medline Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K152948. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medline Anti-Fog Solution?

Medline Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Medline Industries, Inc.. The 510(k) number is K152948.

When did Medline Anti-Fog Solution receive FDA 510(k) clearance?

Medline Anti-Fog Solution received FDA 510(k) clearance on 2016-02-04, under 510(k) number K152948.

Who is the listed applicant for Medline Anti-Fog Solution?

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

What is the FDA product code for Medline Anti-Fog Solution?

The FDA product code for Medline Anti-Fog Solution is OCT.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Medline Industries, Inc. como candidato(a)

K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K222665Medline UNITE® Ankle Fusion Plating System K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe K212911Konig Mogen Clamp K220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser

Ver todos os 74 dispositivos →

Dispositivos Relacionados (Código: OCT)

K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.K231822GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc.K221293E-Brik Visualization AssistantJdi Surgical, Inc.K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler K181887Solução Anti-Nebulização AMDAdvanced Medical Design Co., Ltd.K163257VitreOx Anti-fog SolutionSio2 Nanotech, LLC

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.