CER-S
K-Number: K243312 · 2025-02-20
ApplicantCardiocalm Srl
Decision Date2025-02-20
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CER-S is a medical device manufactured by Cardiocalm Srl. It received FDA 510(k) clearance on 2025-02-20 under approval number K243312. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CER-S?
CER-S is a medical device that received FDA 510(k) clearance on 2025-02-20. It is manufactured by Cardiocalm Srl. The 510(k) number is K243312.
When was CER-S approved by the FDA?
CER-S received FDA 510(k) clearance on 2025-02-20, under approval number K243312.
What company makes CER-S?
CER-S is manufactured by Cardiocalm Srl.
What is the FDA product code for CER-S?
The FDA product code for CER-S is DQK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.