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FDA 510(k)

COR12 ECG

K-Number: K183369 · 2018-12-28

ApplicantCorscience GmbH & Co.
Decision Date2018-12-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COR12 ECG is a medical device manufactured by Corscience GmbH & Co.. It received FDA 510(k) clearance on 2018-12-28 under approval number K183369. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COR12 ECG?

COR12 ECG is a medical device that received FDA 510(k) clearance on 2018-12-28. It is manufactured by Corscience GmbH & Co.. The 510(k) number is K183369.

When was COR12 ECG approved by the FDA?

COR12 ECG received FDA 510(k) clearance on 2018-12-28, under approval number K183369.

What company makes COR12 ECG?

COR12 ECG is manufactured by Corscience GmbH & Co..

What is the FDA product code for COR12 ECG?

The FDA product code for COR12 ECG is DPS.

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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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