Devices · Shenzhen Carewell Electronics Co., Ltd.

AI-ECG Tracker

510(k)K200036CardiovascularDPS

Shenzhen Carewell Electronics Co., Ltd. is listed for AI-ECG Tracker (K200036). The FDA list gives March 20, 2020 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 DPS. 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=K200036

Official FDA database record

Date of final decision: March 20, 2020
Company on the FDA list: Shenzhen Carewell Electronics Co., Ltd.
Lead panel: Cardiovascular
Primary product code: DPS
openFDA device name for the code: Electrocardiograph
Device class: 2
Regulation number: 870.2340
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary