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 the device name listed in this FDA 510(k) record. The listed applicant is Cardiocalm Srl. It received FDA 510(k) clearance on 2022-04-25 under 510(k) 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. The listed applicant is Cardiocalm Srl. The 510(k) number is K213861.

When did CER-S receive FDA 510(k) clearance?

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

Who is the listed applicant for CER-S?

The FDA 510(k) record lists Cardiocalm Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CER-S?

The FDA product code for CER-S is DQK.

Other records listing Cardiocalm Srl as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243312CER-S

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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.