Devices · Ultromics Limited

EchoGo Heart Failure (2.0)

Ultromics Limited is listed for EchoGo Heart Failure (2.0) (K240013). The FDA list gives September 23, 2024 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QUO as “Adjunctive Heart Failure Status Indicator”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240013

Official FDA database record

Date of final decision

September 23, 2024

Company on the FDA list

Ultromics Limited

Lead panel

Cardiovascular

Primary product code

QUO

openFDA device name for the code

Adjunctive Heart Failure Status Indicator

Device class

2

Regulation number

870.2200

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary