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FDA 510(k)

Holter ECG and ABP system (HolterABP)

K-Number: K251591 · 2026-02-09

ApplicantEdan Instruments, Inc.
Decision Date2026-02-09
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Holter ECG and ABP system (HolterABP) is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2026-02-09 under approval number K251591. 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 Holter ECG and ABP system (HolterABP)?

Holter ECG and ABP system (HolterABP) is a medical device that received FDA 510(k) clearance on 2026-02-09. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K251591.

When was Holter ECG and ABP system (HolterABP) approved by the FDA?

Holter ECG and ABP system (HolterABP) received FDA 510(k) clearance on 2026-02-09, under approval number K251591.

What company makes Holter ECG and ABP system (HolterABP)?

Holter ECG and ABP system (HolterABP) is manufactured by Edan Instruments, Inc..

What is the FDA product code for Holter ECG and ABP system (HolterABP)?

The FDA product code for Holter ECG and ABP system (HolterABP) is DQK.

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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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