Etiometry Platform (DAV 5.4 RAE 9.2)
K-Number: K241479 · 2025-02-12
ApplicantEtiometry, Inc.
Decision Date2025-02-12
Product CodePPW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Etiometry Platform (DAV 5.4 RAE 9.2) is a medical device manufactured by Etiometry, Inc.. It received FDA 510(k) clearance on 2025-02-12 under approval number K241479. The device is classified under product code PPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Etiometry Platform (DAV 5.4 RAE 9.2)?
Etiometry Platform (DAV 5.4 RAE 9.2) is a medical device that received FDA 510(k) clearance on 2025-02-12. It is manufactured by Etiometry, Inc.. The 510(k) number is K241479.
When was Etiometry Platform (DAV 5.4 RAE 9.2) approved by the FDA?
Etiometry Platform (DAV 5.4 RAE 9.2) received FDA 510(k) clearance on 2025-02-12, under approval number K241479.
What company makes Etiometry Platform (DAV 5.4 RAE 9.2)?
Etiometry Platform (DAV 5.4 RAE 9.2) is manufactured by Etiometry, Inc..
What is the FDA product code for Etiometry Platform (DAV 5.4 RAE 9.2)?
The FDA product code for Etiometry Platform (DAV 5.4 RAE 9.2) is PPW.
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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.