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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Etiometry, Inc.. It received FDA 510(k) clearance on 2025-02-12 under 510(k) 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. The listed applicant is Etiometry, Inc.. The 510(k) number is K241479.

When did Etiometry Platform (DAV 5.4 RAE 9.2) receive FDA 510(k) clearance?

Etiometry Platform (DAV 5.4 RAE 9.2) received FDA 510(k) clearance on 2025-02-12, under 510(k) number K241479.

Who is the listed applicant for Etiometry Platform (DAV 5.4 RAE 9.2)?

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

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.

Other records listing Etiometry, Inc. as applicant

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.

K254066Etiometry PlatformK223578T3 Platform softwareK213423T3 Platform softwareK213230T3 Platform SoftwareK202306T3 Platform softwareK190273T3 Platform software

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Related Devices (Code: PPW)

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.

K254066Etiometry PlatformEtiometry, Inc.K252204prolaio eVO2peak Module (Version 1.0)Prolaio, Inc.K223578T3 Platform softwareEtiometry, Inc.K213230T3 Platform SoftwareEtiometry, Inc.K213255CipherOx CRI TabletFlashback Technologies, Inc.K173929CipherOx CRI M1Flashback Technologies, Inc.

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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