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FDA 510(k)

Disposable SpO2 Sensors, Reusable SpO2 Sensors

K-Number: K181270 · 2018-09-07

ApplicantOrantech, Inc.
Decision Date2018-09-07
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Disposable SpO2 Sensors, Reusable SpO2 Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Orantech, Inc.. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K181270. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable SpO2 Sensors, Reusable SpO2 Sensors?

Disposable SpO2 Sensors, Reusable SpO2 Sensors is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Orantech, Inc.. The 510(k) number is K181270.

When did Disposable SpO2 Sensors, Reusable SpO2 Sensors receive FDA 510(k) clearance?

Disposable SpO2 Sensors, Reusable SpO2 Sensors received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181270.

Who is the listed applicant for Disposable SpO2 Sensors, Reusable SpO2 Sensors?

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

What is the FDA product code for Disposable SpO2 Sensors, Reusable SpO2 Sensors?

The FDA product code for Disposable SpO2 Sensors, Reusable SpO2 Sensors is DQA.

Other records listing Orantech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182327Patient Cables and Leadwires , Disposable ECG LeadwiresK173194Temperature ProbeK173197Reusable NIBP CuffK171828ETCO2 Sensor

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse 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 SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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