FDA 510(k)

Masimo Rad-67 Pulse CO-Oximeter and Accessories

K-Number: K182887 · 2019-03-22

Decision Date2019-03-22

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Masimo Rad-67 Pulse CO-Oximeter and Accessories is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2019-03-22 under approval number K182887. 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 Rad-67 Pulse CO-Oximeter and Accessories?

Masimo Rad-67 Pulse CO-Oximeter and Accessories is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Masimo Corporation. The 510(k) number is K182887.

When was Masimo Rad-67 Pulse CO-Oximeter and Accessories approved by the FDA?

Masimo Rad-67 Pulse CO-Oximeter and Accessories received FDA 510(k) clearance on 2019-03-22, under approval number K182887.

What company makes Masimo Rad-67 Pulse CO-Oximeter and Accessories?

Masimo Rad-67 Pulse CO-Oximeter and Accessories is manufactured by Masimo Corporation.

What is the FDA product code for Masimo Rad-67 Pulse CO-Oximeter and Accessories?

The FDA product code for Masimo Rad-67 Pulse CO-Oximeter and Accessories is DQA.

Related Clinical Trials

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Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.

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.