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FDA 510(k)

MEDIBLU ECG SYSTEM

K-Number: K233266 · 2024-06-12

ApplicantMediblu Medical, LLC
Decision Date2024-06-12
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDIBLU ECG SYSTEM is a medical device manufactured by Mediblu Medical, LLC. It received FDA 510(k) clearance on 2024-06-12 under approval number K233266. 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 MEDIBLU ECG SYSTEM?

MEDIBLU ECG SYSTEM is a medical device that received FDA 510(k) clearance on 2024-06-12. It is manufactured by Mediblu Medical, LLC. The 510(k) number is K233266.

When was MEDIBLU ECG SYSTEM approved by the FDA?

MEDIBLU ECG SYSTEM received FDA 510(k) clearance on 2024-06-12, under approval number K233266.

What company makes MEDIBLU ECG SYSTEM?

MEDIBLU ECG SYSTEM is manufactured by Mediblu Medical, LLC.

What is the FDA product code for MEDIBLU ECG SYSTEM?

The FDA product code for MEDIBLU ECG SYSTEM 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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