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 a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2023-09-25 under approval 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. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K230184.
When was Holter ECG and ABP System approved by the FDA?
Holter ECG and ABP System received FDA 510(k) clearance on 2023-09-25, under approval number K230184.
What company makes Holter ECG and ABP System?
Holter ECG and ABP System is manufactured by Edan Instruments, Inc..
What is the FDA product code for Holter ECG and ABP System?
The FDA product code for Holter ECG and ABP System is DSH.
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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.