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510(k) K213423

T3 Platform software by Etiometry, Inc. — Product Code PLB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 6, 2023
Date Received: October 20, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Multivariate Vital Signs Index
Device Class: Class II
Regulation Number: 870.2300
Review Panel: CV
Submission Type

Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.

Other clearances by Etiometry, Inc.

K241479 — Etiometry Platform (DAV 5.4 RAE 9.2) (February 12, 2025)
K223578 — T3 Platform software (July 7, 2023)
K213230 — T3 Platform Software (June 22, 2022)
K202306 — T3 Platform software (November 25, 2020)
K190273 — T3 Platform software (December 8, 2019)
K163065 — T3 Software (May 26, 2017)
K152258 — T3 Software (March 31, 2016)
K151715 — T3 Software (October 29, 2015)
K142732 — T3 Software (March 4, 2015)