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FDA 510(k)

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)

K-Number: K252463 · 2026-07-02

ApplicantEdan Instruments, Inc.
Decision Date2026-07-02
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K252463. 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 SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)?

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K252463.

When did SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) receive FDA 510(k) clearance?

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) received FDA 510(k) clearance on 2026-07-02, under 510(k) number K252463.

Who is the listed applicant for SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)?

The FDA product code for SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) 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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