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FDA 510(k)

ECHOENCODER

K-Number: K032324 · 2003-10-02

ApplicantIcardiogram, Incorporated
Decision Date2003-10-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHOENCODER is the device name listed in this FDA 510(k) record. The listed applicant is Icardiogram, Incorporated. It received FDA 510(k) clearance on 2003-10-02 under 510(k) number K032324. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOENCODER?

ECHOENCODER is a medical device that received FDA 510(k) clearance on 2003-10-02. The listed applicant is Icardiogram, Incorporated. The 510(k) number is K032324.

When did ECHOENCODER receive FDA 510(k) clearance?

ECHOENCODER received FDA 510(k) clearance on 2003-10-02, under 510(k) number K032324.

Who is the listed applicant for ECHOENCODER?

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

What is the FDA product code for ECHOENCODER?

The FDA product code for ECHOENCODER is LLZ.

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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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