Holter System
K-Number: K151787 · 2016-01-27
ApplicantEdan Instruments, Inc.
Decision Date2016-01-27
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Holter System is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-01-27 under approval number K151787. 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 System?
Holter System is a medical device that received FDA 510(k) clearance on 2016-01-27. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K151787.
When was Holter System approved by the FDA?
Holter System received FDA 510(k) clearance on 2016-01-27, under approval number K151787.
What company makes Holter System?
Holter System is manufactured by Edan Instruments, Inc..
What is the FDA product code for Holter System?
The FDA product code for Holter System 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.