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FDA 510(k)

Masimo Rad-97 Pulse CO-Oximeter and Accessories

K-Number: K193626 · 2020-08-10

ApplicantMasimo Corporation
Decision Date2020-08-10
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo Rad-97 Pulse CO-Oximeter and Accessories is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2020-08-10 under approval number K193626. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Masimo Rad-97 Pulse CO-Oximeter and Accessories?

Masimo Rad-97 Pulse CO-Oximeter and Accessories is a medical device that received FDA 510(k) clearance on 2020-08-10. It is manufactured by Masimo Corporation. The 510(k) number is K193626.

When was Masimo Rad-97 Pulse CO-Oximeter and Accessories approved by the FDA?

Masimo Rad-97 Pulse CO-Oximeter and Accessories received FDA 510(k) clearance on 2020-08-10, under approval number K193626.

What company makes Masimo Rad-97 Pulse CO-Oximeter and Accessories?

Masimo Rad-97 Pulse CO-Oximeter and Accessories is manufactured by Masimo Corporation.

What is the FDA product code for Masimo Rad-97 Pulse CO-Oximeter and Accessories?

The FDA product code for Masimo Rad-97 Pulse CO-Oximeter and Accessories is MWI.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT06432881 Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE) RECRUITING NCT05914324 Outpatient Pediatric Pulse Oximeters in Africa ACTIVE_NOT_RECRUITING NCT05690633 Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx COMPLETED

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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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