Data / Medical devices / Italy / Cardiocalm SRL
Cardiocalm SRL: FDA-registered device maker in Montichiari Brescia, Italy, 3 510(k) clearances
Cardiocalm SRL is registered with the FDA (registration 3017840980) in Montichiari Brescia, Italy. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 20, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017840980
- Address
- Via Martiri della Liberta 40, Montichiari Brescia, Italy, 25018
- Owner or operator
- CardioCalm Srl (10078909)
- Roles
- Manufacturer
- First device listed
- November 10, 2020
- Registered through
- 2027
- Brand names listed
- CER-S, CER-S Continuous ECG Recording - Suite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2025 | K243312 | CER-S | DQK | Substantially Equivalent | Cardiocalm Srl | accessdata.fda.gov |
| April 25, 2022 | K213861 | CER-S | DQK | Substantially Equivalent | Cardiocalm Srl | accessdata.fda.gov |
| August 26, 2020 | K193177 | CER-S | MLO | Substantially Equivalent | Cardiocalm | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
Updated February 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.