FDA 510(k)

Masimo W1

K-Number: K240229 · 2024-08-08

Decision Date2024-08-08

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Masimo W1 is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K240229. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Masimo W1?

Masimo W1 is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Masimo Corporation. The 510(k) number is K240229.

When did Masimo W1 receive FDA 510(k) clearance?

Masimo W1 received FDA 510(k) clearance on 2024-08-08, under 510(k) number K240229.

Who is the listed applicant for Masimo W1?

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

What is the FDA product code for Masimo W1?

The FDA product code for Masimo W1 is DPS.

Related Clinical Trials

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.

NCT02986789Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical OutcomesTERMINATED NCT03706430Validation of RPVi as a Parameter to Predict Fluid ResponsivenessTERMINATED NCT06289556Clinical Performance of Masimo INVSENSOR00048TERMINATED NCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETED NCT06922461Clinical Performance of Masimo INVSENSOR00048 (DALI0001)TERMINATED NCT07223164Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular DiseaseCOMPLETED

Other records listing Masimo Corporation as applicant

K253417Masimo Root Monitoring System K260880SedLine Sedation Monitor K254209Radius VSM and Accessories K243324Masimo O3 Regional Oximeter K250757Radius VSM and Accessories K243305Masimo W1

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Related Devices (Code: DPS)

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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.