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FDA 510(k)

Electrocardiograph: SE-1200 Pro and SE-1201 Pro

K-Number: K222902 · 2023-07-28

ApplicantEdan Instruments, Inc.
Decision Date2023-07-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electrocardiograph: SE-1200 Pro and SE-1201 Pro is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2023-07-28 under approval number K222902. 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-1200 Pro and SE-1201 Pro?

Electrocardiograph: SE-1200 Pro and SE-1201 Pro is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K222902.

When was Electrocardiograph: SE-1200 Pro and SE-1201 Pro approved by the FDA?

Electrocardiograph: SE-1200 Pro and SE-1201 Pro received FDA 510(k) clearance on 2023-07-28, under approval number K222902.

What company makes Electrocardiograph: SE-1200 Pro and SE-1201 Pro?

Electrocardiograph: SE-1200 Pro and SE-1201 Pro is manufactured by Edan Instruments, Inc..

What is the FDA product code for Electrocardiograph: SE-1200 Pro and SE-1201 Pro?

The FDA product code for Electrocardiograph: SE-1200 Pro and SE-1201 Pro 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.

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