FDA 510(k)

LOGIQ E10

K-Number: K200158 · 2020-04-17

ApplicantGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Decision Date2020-04-17

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LOGIQ E10 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2020-04-17 under 510(k) number K200158. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOGIQ E10?

LOGIQ E10 is a medical device that received FDA 510(k) clearance on 2020-04-17. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K200158.

When did LOGIQ E10 receive FDA 510(k) clearance?

LOGIQ E10 received FDA 510(k) clearance on 2020-04-17, under 510(k) number K200158.

Who is the listed applicant for LOGIQ E10?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIQ E10?

The FDA product code for LOGIQ E10 is IYN.

Other records listing GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.