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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K213861
Device Name CER-S
Applicant
Cardiocalm Srl
Via Martiri Della Liberta, Nr. 40
Montichiari,  IT 25018
Applicant Contact Fabio Badilini
Correspondent
Cardiocalm Srl
Via Martiri Della Liberta, Nr. 40
Montichiari,  IT 25018
Correspondent Contact Fabio Badilini
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/10/2021
Decision Date 04/25/2022
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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