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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K252440
Device Name EasyTeleMed (2.0.2)
Applicant
Ingeniars S.R.L.
Via Ponte A Piglieri 8
Pisa,  IT 56121
Applicant Contact Silvia Panicacci
Correspondent
Ingeniars S.R.L.
Via Ponte A Piglieri 8
Pisa,  IT 56121
Correspondent Contact Silvia Panicacci
Regulation Number870.2910
Classification Product Code
DRG  
Date Received08/04/2025
Decision Date 10/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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