FDA 510(k)

EchoMark, EchoMark LP

K-Number: K180621 · 2018-06-06

Decision Date2018-06-06

Product CodeNEU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EchoMark, EchoMark LP is a medical device manufactured by Sonavex, Inc.. It received FDA 510(k) clearance on 2018-06-06 under approval number K180621. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoMark, EchoMark LP?

EchoMark, EchoMark LP is a medical device that received FDA 510(k) clearance on 2018-06-06. It is manufactured by Sonavex, Inc.. The 510(k) number is K180621.

When was EchoMark, EchoMark LP approved by the FDA?

EchoMark, EchoMark LP received FDA 510(k) clearance on 2018-06-06, under approval number K180621.

What company makes EchoMark, EchoMark LP?

EchoMark, EchoMark LP is manufactured by Sonavex, Inc..

What is the FDA product code for EchoMark, EchoMark LP?

The FDA product code for EchoMark, EchoMark LP is NEU.

Other Devices by Sonavex, Inc.

K190039EchoSure Diagnostic Ultrasound System K243479EchoGuide (Version 1)

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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.