FDA 510(k)

Med-Link Temp-pulse Oximeter

N.º K: K202743 · 2021-03-01

SolicitanteShenzhen Med-Link Electronics Tech Co., Ltd.

Fecha de decisión2021-03-01

Código de productoDQA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Med-Link Temp-pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K202743. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Med-Link Temp-pulse Oximeter?

Med-Link Temp-pulse Oximeter is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K202743.

When did Med-Link Temp-pulse Oximeter receive FDA 510(k) clearance?

Med-Link Temp-pulse Oximeter received FDA 510(k) clearance on 2021-03-01, under 510(k) number K202743.

Who is the listed applicant for Med-Link Temp-pulse Oximeter?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-Link Temp-pulse Oximeter?

The FDA product code for Med-Link Temp-pulse Oximeter is DQA.

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Otros registros que enlistan a Shenzhen Med-Link Electronics Tech Co., Ltd. como solicitante

K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)K220448Disposable Non-invasive EEG Sensor K220447Med-link Disposable ECG Cable and Leadwires K212752Med-link Pulse Oximeter K210441Incontinence Probe K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

Ver todos los 11 dispositivos →

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.K252448Pulsoxímetro AViTA (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Fuente oficial

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