Devices · Kestra Medical Technologies, Inc.

ASSURE Wearable ECG

510(k)K233864CardiovascularMWJ

Kestra Medical Technologies, Inc. is listed for ASSURE Wearable ECG (K233864). The FDA list gives May 7, 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. The primary product code on the FDA list is MWJ. openFDA did not return a classification record for that code in this copy of the data. 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=K233864

Official FDA database record

Date of final decision: May 7, 2024
Company on the FDA list: Kestra Medical Technologies, Inc.
Lead panel: Cardiovascular
Primary product code: MWJ
openFDA device name for the code: Electrocardiograph, Ambulatory (Without Analysis)
Device class: 2
Regulation number: 870.2800
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary