Devices · AgileMD, Inc.

eCARTv5 Clinical Deterioration Suite (“eCART”)

AgileMD, Inc. is listed for eCARTv5 Clinical Deterioration Suite (“eCART”) (K233253). The FDA list gives June 21, 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 QNL as “Medium-Term Adjunctive Predictive Cardiovascular Indicator”: The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. 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=K233253

Official FDA database record

Date of final decision

June 21, 2024

Company on the FDA list

AgileMD, Inc.

Lead panel

Cardiovascular

Primary product code

QNL

openFDA device name for the code

Medium-Term Adjunctive Predictive Cardiovascular Indicator

Device class

2

Regulation number

870.2210

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary