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FDA 510(k)

CER-S

K-Number: K193177 · 2020-08-26

ApplicantCardiocalm
Decision Date2020-08-26
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CER-S is a medical device manufactured by Cardiocalm. It received FDA 510(k) clearance on 2020-08-26 under approval number K193177. The device is classified under product code MLO. 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 2020-08-26. It is manufactured by Cardiocalm. The 510(k) number is K193177.

When was CER-S approved by the FDA?

CER-S received FDA 510(k) clearance on 2020-08-26, under approval number K193177.

What company makes CER-S?

CER-S is manufactured by Cardiocalm.

What is the FDA product code for CER-S?

The FDA product code for CER-S is MLO.

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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.

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