FDA 510(k)

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

Numéro K : K172625 · 2018-05-11

Date de décision2018-05-11

Code produitDQA

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor 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 2018-05-11 under 510(k) number K172625. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor?

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K172625.

When did Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor receive FDA 510(k) clearance?

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor received FDA 510(k) clearance on 2018-05-11, under 510(k) number K172625.

Who is the listed applicant for Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor?

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 Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor?

The FDA product code for Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor is DQA.

Essais cliniques associés

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Autres dossiers indiquant Nonin Medical, Inc. en tant que demandeur

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 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

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Dispositifs connexes (Code : 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 Oxymètre de Pouls (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Source officielle

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