FDA 510(k)

Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)

Número K: K210032 · 2021-09-01

Data da decisão2021-09-01

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) is the device name listed in this FDA 510(k) record. The listed applicant is Leadtek Research, Inc.. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K210032. 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 Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)?

Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Leadtek Research, Inc.. The 510(k) number is K210032.

When did Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) receive FDA 510(k) clearance?

Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) received FDA 510(k) clearance on 2021-09-01, under 510(k) number K210032.

Who is the listed applicant for Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)?

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

What is the FDA product code for Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)?

The FDA product code for Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) is DQA.

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Outros registros que listam Leadtek Research, Inc. como candidato(a)

K193350Leadtek Fingertip Pulse Oximeter

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.

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