EchoGo Pro— 510(k) K201555

Substantially Equivalent

Ultromics, Ltd.

FDA 510(k) clearance K201555 for EchoGo Pro, Substantially Equivalent on 2020-12-18. Applicant: Ultromics, Ltd.. Device class: 2.

Clearance details

Applicant: Ultromics, Ltd.
Product code: Code POK
Device class: Class 2
Regulation: 21 CFR 892.2060
Advisory panel: Radiology
Date received: 2020-06-10
Decision date: 2020-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.