Cleared Traditional

EasyTeleMed (2.0.2)

K252440 · Ingeniars S.R.L. · Cardiovascular

Oct 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K252440 is an FDA 510(k) clearance for the EasyTeleMed (2.0.2), a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Ingeniars S.R.L. (Pisa, IT). The FDA issued a Cleared decision on October 2, 2025, 59 days after receiving the submission on August 4, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K252440 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2025
Decision Date	October 02, 2025
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910