FDA 510(k)

Oxímetro de Pulso de Tipo de Dedo

Número K: K151024 · 2016-03-02

Data da decisão2016-03-02

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Finger Type Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K151024. 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 Finger Type Pulse Oximeter?

Finger Type Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K151024.

When did Finger Type Pulse Oximeter receive FDA 510(k) clearance?

Finger Type Pulse Oximeter received FDA 510(k) clearance on 2016-03-02, under 510(k) number K151024.

Who is the listed applicant for Finger Type Pulse Oximeter?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Finger Type Pulse Oximeter?

The FDA product code for Finger Type Pulse Oximeter is DQA.

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Dispositivos Relacionados (Código: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse 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 Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Oxímetro de Pulso (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Fonte oficial

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