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FDA 510(k)

PC ECG, MODEL SE-1010

K-Number: K092010 · 2009-10-22

ApplicantEdan Instruments, Inc.
Decision Date2009-10-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PC ECG, MODEL SE-1010 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 2009-10-22 under 510(k) number K092010. 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 PC ECG, MODEL SE-1010?

PC ECG, MODEL SE-1010 is a medical device that received FDA 510(k) clearance on 2009-10-22. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K092010.

When did PC ECG, MODEL SE-1010 receive FDA 510(k) clearance?

PC ECG, MODEL SE-1010 received FDA 510(k) clearance on 2009-10-22, under 510(k) number K092010.

Who is the listed applicant for PC ECG, MODEL SE-1010?

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 PC ECG, MODEL SE-1010?

The FDA product code for PC ECG, MODEL SE-1010 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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