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FDA 510(k)

SE-601 SERIES ELECTROCARDIOGRAPH

K-Number: K090367 · 2009-06-03

ApplicantEdan Instruments, Inc.
Decision Date2009-06-03
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SE-601 SERIES ELECTROCARDIOGRAPH 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 2009-06-03 under 510(k) number K090367. 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-601 SERIES ELECTROCARDIOGRAPH?

SE-601 SERIES ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 2009-06-03. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K090367.

When did SE-601 SERIES ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

SE-601 SERIES ELECTROCARDIOGRAPH received FDA 510(k) clearance on 2009-06-03, under 510(k) number K090367.

Who is the listed applicant for SE-601 SERIES ELECTROCARDIOGRAPH?

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-601 SERIES ELECTROCARDIOGRAPH?

The FDA product code for SE-601 SERIES ELECTROCARDIOGRAPH is DPS.

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Related Devices (Code: 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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