electrocardiograph: SE-1202
K-Number: K210140 · 2021-10-01
ApplicantEdan Instruments, Inc.
Decision Date2021-10-01
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
electrocardiograph: SE-1202 is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2021-10-01 under approval number K210140. 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: SE-1202?
electrocardiograph: SE-1202 is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K210140.
When was electrocardiograph: SE-1202 approved by the FDA?
electrocardiograph: SE-1202 received FDA 510(k) clearance on 2021-10-01, under approval number K210140.
What company makes electrocardiograph: SE-1202?
electrocardiograph: SE-1202 is manufactured by Edan Instruments, Inc..
What is the FDA product code for electrocardiograph: SE-1202?
The FDA product code for electrocardiograph: SE-1202 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.