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FDA 510(k)

Masimo Disposable Transflectance Forehead Sensor

K-Number: K160940 · 2016-11-23

ApplicantMasimo Corporation
Decision Date2016-11-23
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo Disposable Transflectance Forehead Sensor is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2016-11-23 under approval number K160940. 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 Masimo Disposable Transflectance Forehead Sensor?

Masimo Disposable Transflectance Forehead Sensor is a medical device that received FDA 510(k) clearance on 2016-11-23. It is manufactured by Masimo Corporation. The 510(k) number is K160940.

When was Masimo Disposable Transflectance Forehead Sensor approved by the FDA?

Masimo Disposable Transflectance Forehead Sensor received FDA 510(k) clearance on 2016-11-23, under approval number K160940.

What company makes Masimo Disposable Transflectance Forehead Sensor?

Masimo Disposable Transflectance Forehead Sensor is manufactured by Masimo Corporation.

What is the FDA product code for Masimo Disposable Transflectance Forehead Sensor?

The FDA product code for Masimo Disposable Transflectance Forehead Sensor is DQA.

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Related Devices (Code: 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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