FDA 510(k)

Caremed Reusable & Disposable SPO2 Sensors

N.º K: K153184 · 2017-01-04

SolicitanteShenzhen Caremed Medical Technology Co., Ltd.

Fecha de decisión2017-01-04

Código de productoDQA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Caremed Reusable & Disposable SPO2 Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K153184. 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 Caremed Reusable & Disposable SPO2 Sensors?

Caremed Reusable & Disposable SPO2 Sensors is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. The 510(k) number is K153184.

When did Caremed Reusable & Disposable SPO2 Sensors receive FDA 510(k) clearance?

Caremed Reusable & Disposable SPO2 Sensors received FDA 510(k) clearance on 2017-01-04, under 510(k) number K153184.

Who is the listed applicant for Caremed Reusable & Disposable SPO2 Sensors?

The FDA 510(k) record lists Shenzhen Caremed Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Caremed Reusable & Disposable SPO2 Sensors?

The FDA product code for Caremed Reusable & Disposable SPO2 Sensors is DQA.

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Otros registros que enlistan a Shenzhen Caremed Medical Technology Co., Ltd. como solicitante

K191279Disposable SpO2 Sensor K182751Reusable Temperature Probe K182755Disposable Temperature Probe K182433Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff K153188Caremed patient cable and leadwires

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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