FDA 510(k)

Pulse Oximeter (Model C101A2, C101B1, C101A3)

N.º K: K221979 · 2022-10-16

SolicitanteShenzhen Imdk Medical Technology Co., Ltd.

Fecha de decisión2022-10-16

Código de productoDQA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pulse Oximeter (Model C101A2, C101B1, C101A3) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-16 under 510(k) number K221979. 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 Pulse Oximeter (Model C101A2, C101B1, C101A3)?

Pulse Oximeter (Model C101A2, C101B1, C101A3) is a medical device that received FDA 510(k) clearance on 2022-10-16. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K221979.

When did Pulse Oximeter (Model C101A2, C101B1, C101A3) receive FDA 510(k) clearance?

Pulse Oximeter (Model C101A2, C101B1, C101A3) received FDA 510(k) clearance on 2022-10-16, under 510(k) number K221979.

Who is the listed applicant for Pulse Oximeter (Model C101A2, C101B1, C101A3)?

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

What is the FDA product code for Pulse Oximeter (Model C101A2, C101B1, C101A3)?

The FDA product code for Pulse Oximeter (Model C101A2, C101B1, C101A3) is DQA.

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

K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)K253133Wrist Blood Pressure Monitor (BPM-W1VL)K243118Monitor de Presión Arterial de Brazo (modelo: BPM-A7VL)K233040EMS/TENS Massager Device K173123Pulse Oximeter K180419Ultrasonic Doppler (Model YM-2T8)

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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.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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