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FDA 510(k)

HD+12, HD+15

K-Number: K220526 · 2023-05-15

ApplicantCardioline S.P.A
Decision Date2023-05-15
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HD+12, HD+15 is a medical device manufactured by Cardioline S.P.A. It received FDA 510(k) clearance on 2023-05-15 under approval number K220526. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD+12, HD+15?

HD+12, HD+15 is a medical device that received FDA 510(k) clearance on 2023-05-15. It is manufactured by Cardioline S.P.A. The 510(k) number is K220526.

When was HD+12, HD+15 approved by the FDA?

HD+12, HD+15 received FDA 510(k) clearance on 2023-05-15, under approval number K220526.

What company makes HD+12, HD+15?

HD+12, HD+15 is manufactured by Cardioline S.P.A.

What is the FDA product code for HD+12, HD+15?

The FDA product code for HD+12, HD+15 is DRG.

Other Devices by Cardioline S.P.A

K160746CARDIOLINE touchECG K160840ECG100+, ECG200+

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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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