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FDA 510(k)

EchoGo Pro

K-Number: K201555 · 2020-12-18

ApplicantUltromics, Ltd.
Decision Date2020-12-18
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoGo Pro is the device name listed in this FDA 510(k) record. The listed applicant is Ultromics, Ltd.. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K201555. 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 EchoGo Pro?

EchoGo Pro is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Ultromics, Ltd.. The 510(k) number is K201555.

When did EchoGo Pro receive FDA 510(k) clearance?

EchoGo Pro received FDA 510(k) clearance on 2020-12-18, under 510(k) number K201555.

Who is the listed applicant for EchoGo Pro?

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

What is the FDA product code for EchoGo Pro?

The FDA product code for EchoGo Pro is POK.

Other records listing Ultromics, Ltd. 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.

K240860EchoGo Amyloidosis (1.0)K240013EchoGo Heart Failure (2.0)K222463EchoGo Heart FailureK213275EchoGo Core (2.0)K191171EchoGo Core

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.

K253884Koios DS (3.8)Koios Medical, Inc.K261519Sonio SuspectSonioK254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK251769RevealAI-LungPrecision Medical Ventures, Inc. Dba RevealdxK252294Fetal EchoScan (v1.2)BrightheartK250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc.

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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