510(k) K252440

EasyTeleMed (2.0.2) by Ingeniars S.R.L. — Product Code DRG

K252440 is an FDA 510(k) premarket notification submitted by Ingeniars S.R.L. for the device "EasyTeleMed (2.0.2)". The FDA issued a decision of Substantially Equivalent on October 2, 2025. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2025
Date Received
August 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type