Masimo W1
K-Number: K243305 · 2025-04-03
ApplicantMasimo Corporation
Decision Date2025-04-03
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Masimo W1 is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2025-04-03 under approval number K243305. 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 2025-04-03. It is manufactured by Masimo Corporation. The 510(k) number is K243305.
When was Masimo W1 approved by the FDA?
Masimo W1 received FDA 510(k) clearance on 2025-04-03, under approval number K243305.
What company makes Masimo W1?
Masimo W1 is manufactured by Masimo Corporation.
What is the FDA product code for Masimo W1?
The FDA product code for Masimo W1 is 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.