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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 a medical device manufactured by Orantech, Inc.. It received FDA 510(k) clearance on 2018-09-07 under approval 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. It is manufactured by Orantech, Inc.. The 510(k) number is K181270.

When was Disposable SpO2 Sensors, Reusable SpO2 Sensors approved by the FDA?

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

What company makes Disposable SpO2 Sensors, Reusable SpO2 Sensors?

Disposable SpO2 Sensors, Reusable SpO2 Sensors is manufactured by Orantech, Inc..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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