FDA 510(k)

Fingertip Pulse Oximeter MD300CG11/MD300CG51

N.º K: K160268 · 2016-10-14

SolicitanteBeijing Choice Electronic Technology Co., Ltd.

Fecha de decisión2016-10-14

Código de productoDQA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Fingertip Pulse Oximeter MD300CG11/MD300CG51 is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K160268. 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 Fingertip Pulse Oximeter MD300CG11/MD300CG51?

Fingertip Pulse Oximeter MD300CG11/MD300CG51 is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. The 510(k) number is K160268.

When did Fingertip Pulse Oximeter MD300CG11/MD300CG51 receive FDA 510(k) clearance?

Fingertip Pulse Oximeter MD300CG11/MD300CG51 received FDA 510(k) clearance on 2016-10-14, under 510(k) number K160268.

Who is the listed applicant for Fingertip Pulse Oximeter MD300CG11/MD300CG51?

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

What is the FDA product code for Fingertip Pulse Oximeter MD300CG11/MD300CG51?

The FDA product code for Fingertip Pulse Oximeter MD300CG11/MD300CG51 is DQA.

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Otros registros que enlistan a Beijing Choice Electronic Technology Co., Ltd. como solicitante

K232975Pulse Oximeter (MD300C228)K230587Wrist Pulse Oximeter K230172Pulse Oximeter K220101Pulse Oximeter K221992Electronic Pulse Stimulator K211400Pulse Oximeter

Ver todos los 14 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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