FDA 510(k)

H500 Multi-Sensing Oximetry System

N.º K: K192900 · 2020-06-29

Fecha de decisión2020-06-29

Código de productoDQA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

H500 Multi-Sensing 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 2020-06-29 under 510(k) number K192900. 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 H500 Multi-Sensing Oximetry System?

H500 Multi-Sensing Oximetry System is a medical device that received FDA 510(k) clearance on 2020-06-29. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K192900.

When did H500 Multi-Sensing Oximetry System receive FDA 510(k) clearance?

H500 Multi-Sensing Oximetry System received FDA 510(k) clearance on 2020-06-29, under 510(k) number K192900.

Who is the listed applicant for H500 Multi-Sensing 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 H500 Multi-Sensing Oximetry System?

The FDA product code for H500 Multi-Sensing Oximetry System is DQA.

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Otros registros que enlistan a Nonin Medical, Inc. como solicitante

K211498Nonin OTC Pulse Oximeter Model 3250 K191403Pulse Oximeter K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor K160231Model X-100C CO-Met™ Oximetry System 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

Ver todos los 7 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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