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FDA 510(k)

ECHOINSIGHT

K-Number: K110447 · 2011-05-27

ApplicantUltrasound Medical Devices, Inc.
Decision Date2011-05-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHOINSIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasound Medical Devices, Inc.. It received FDA 510(k) clearance on 2011-05-27 under 510(k) number K110447. 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 ECHOINSIGHT?

ECHOINSIGHT is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Ultrasound Medical Devices, Inc.. The 510(k) number is K110447.

When did ECHOINSIGHT receive FDA 510(k) clearance?

ECHOINSIGHT received FDA 510(k) clearance on 2011-05-27, under 510(k) number K110447.

Who is the listed applicant for ECHOINSIGHT?

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

What is the FDA product code for ECHOINSIGHT?

The FDA product code for ECHOINSIGHT is LLZ.

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Other records listing Ultrasound Medical Devices, 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.

K100363ULTRA DCI MODEL 5000

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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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