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FDA 510(k)

Holter ECG and ABP System

K-Number: K230184 · 2023-09-25

ApplicantEdan Instruments, Inc.
Decision Date2023-09-25
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Holter ECG and ABP System is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K230184. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Holter ECG and ABP System?

Holter ECG and ABP System is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K230184.

When did Holter ECG and ABP System receive FDA 510(k) clearance?

Holter ECG and ABP System received FDA 510(k) clearance on 2023-09-25, under 510(k) number K230184.

Who is the listed applicant for Holter ECG and ABP System?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Holter ECG and ABP System?

The FDA product code for Holter ECG and ABP System is DSH.

Other records listing Edan Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251508Telemetry Monitor (iT30, iT50)K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)K251591Holter ECG and ABP system (HolterABP)K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)K241882Fetal & Maternal Monitor (F15A, F15A Air)K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

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Related Devices (Code: DSH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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