FDA 510(k)

Model X-100C CO-Met™ Oximetry System

Número K: K160231 · 2016-12-23

Data da decisão2016-12-23

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Model X-100C CO-Met™ Oximetry System is the device name listed in this FDA 510(k) record. The listed applicant is Nonin Medical, Inc.. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K160231. 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 Model X-100C CO-Met™ Oximetry System?

Model X-100C CO-Met™ Oximetry System is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K160231.

When did Model X-100C CO-Met™ Oximetry System receive FDA 510(k) clearance?

Model X-100C CO-Met™ Oximetry System received FDA 510(k) clearance on 2016-12-23, under 510(k) number K160231.

Who is the listed applicant for Model X-100C CO-Met™ Oximetry System?

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

What is the FDA product code for Model X-100C CO-Met™ Oximetry System?

The FDA product code for Model X-100C CO-Met™ Oximetry System is DQA.

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Outros registros que listam Nonin Medical, Inc. como candidato(a)

K211498Nonin OTC Pulse Oximeter Model 3250 K192900H500 Multi-Sensing Oximetry System K191403Pulse Oximeter K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso

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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.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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