Electrocardiograph
K-Number: K212278 · 2022-04-07
ApplicantEdan Instruments, Inc.
Decision Date2022-04-07
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Electrocardiograph is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2022-04-07 under approval number K212278. 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 Electrocardiograph?
Electrocardiograph is a medical device that received FDA 510(k) clearance on 2022-04-07. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K212278.
When was Electrocardiograph approved by the FDA?
Electrocardiograph received FDA 510(k) clearance on 2022-04-07, under approval number K212278.
What company makes Electrocardiograph?
Electrocardiograph is manufactured by Edan Instruments, Inc..
What is the FDA product code for Electrocardiograph?
The FDA product code for Electrocardiograph 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.