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FDA 510(k)

ECHOPLAQUE

K-Number: K092842 · 2010-03-01

ApplicantIndec Systems, Inc.
Decision Date2010-03-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHOPLAQUE is the device name listed in this FDA 510(k) record. The listed applicant is Indec Systems, Inc.. It received FDA 510(k) clearance on 2010-03-01 under 510(k) number K092842. 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 ECHOPLAQUE?

ECHOPLAQUE is a medical device that received FDA 510(k) clearance on 2010-03-01. The listed applicant is Indec Systems, Inc.. The 510(k) number is K092842.

When did ECHOPLAQUE receive FDA 510(k) clearance?

ECHOPLAQUE received FDA 510(k) clearance on 2010-03-01, under 510(k) number K092842.

Who is the listed applicant for ECHOPLAQUE?

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

What is the FDA product code for ECHOPLAQUE?

The FDA product code for ECHOPLAQUE is LLZ.

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Other records listing Indec Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062985IVUS ENHANCERK024103IVUS PLUS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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