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510(k) K163065

T3 Software by Etiometry, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2017
Date Received
November 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Etiometry, Inc.

  • K241479 — Etiometry Platform (DAV 5.4 RAE 9.2) (February 12, 2025)
  • K223578 — T3 Platform software (July 7, 2023)
  • K213423 — T3 Platform software (January 6, 2023)
  • K213230 — T3 Platform Software (June 22, 2022)
  • K202306 — T3 Platform software (November 25, 2020)
  • K190273 — T3 Platform software (December 8, 2019)
  • K152258 — T3 Software (March 31, 2016)
  • K151715 — T3 Software (October 29, 2015)
  • K142732 — T3 Software (March 4, 2015)

Other clearances for product code MWI

  • K250135 — WAVE Clinical Platform (2.0.000) (January 16, 2026)
  • K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (August 27, 2025)
  • K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (June 6, 2025)
  • K241958 — WARD-CSS (v1.2.x) (February 14, 2025)
  • K243146 — iCare APP (February 3, 2025)
  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (December 10, 2024)
  • K233446 — AMC Health CareConsole (September 27, 2024)
  • K240236 — Happy Ring Health Monitoring System (September 24, 2024)
  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)