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FDA 510(k)

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors

Número K: K181738 · 2019-03-22

RequerenteSurgical Instrument Service and Savings Inc (Dba Medline
Data da decisão2019-03-22
Código do produtoDQA
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings Inc (Dba Medline. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181738. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors?

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Surgical Instrument Service and Savings Inc (Dba Medline. The 510(k) number is K181738.

When did Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors receive FDA 510(k) clearance?

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181738.

Who is the listed applicant for Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors?

The FDA 510(k) record lists Surgical Instrument Service and Savings Inc (Dba Medline as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors?

The FDA product code for Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors is DQA.

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Dispositivos Relacionados (Código: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Oxímetro de Pulso (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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