FDA 510(k)

CER-S

K-Number: K213861 · 2022-04-25

Decision Date2022-04-25

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 2022-04-25 under approval number K213861. 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 2022-04-25. It is manufactured by Cardiocalm Srl. The 510(k) number is K213861.

When was CER-S approved by the FDA?

CER-S received FDA 510(k) clearance on 2022-04-25, under approval number K213861.

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.

Other Devices by Cardiocalm Srl

K243312CER-S

Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162643MediGuide Technology SystemSt Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt Jude Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.