FDA 510(k)

EchoSolv AS

K-Number: K241245 · 2024-10-04

Decision Date2024-10-04

Product CodePOK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EchoSolv AS is the device name listed in this FDA 510(k) record. The listed applicant is Echo IQ, Ltd.. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241245. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoSolv AS?

EchoSolv AS is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Echo IQ, Ltd.. The 510(k) number is K241245.

When did EchoSolv AS receive FDA 510(k) clearance?

EchoSolv AS received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241245.

Who is the listed applicant for EchoSolv AS?

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

What is the FDA product code for EchoSolv AS?

The FDA product code for EchoSolv AS is POK.

Related Devices (Code: POK)

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.

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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.