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510(k) K240013

EchoGo Heart Failure (2.0) by Ultromics Limited — Product Code QUO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2024
Date Received
January 2, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adjunctive Heart Failure Status Indicator
Device Class
Class II
Regulation Number
870.2200
Review Panel
CV
Submission Type

The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

Other clearances by Ultromics Limited

  • K240860 — EchoGo Amyloidosis (1.0) (November 15, 2024)
  • K222463 — EchoGo Heart Failure (November 23, 2022)
  • K213275 — EchoGo Core (2.0) (December 20, 2021)

Other clearances for product code QUO

  • K251293 — CardioVision (November 21, 2025)
  • K223905 — Vivio® LVEDP System (October 6, 2023)
  • K222463 — EchoGo Heart Failure (November 23, 2022)