LOGIQ E10
K-Number: K200158 · 2020-04-17
Decision Date2020-04-17
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LOGIQ E10 is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2020-04-17 under approval 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. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K200158.
When was LOGIQ E10 approved by the FDA?
LOGIQ E10 received FDA 510(k) clearance on 2020-04-17, under approval number K200158.
What company makes LOGIQ E10?
LOGIQ E10 is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.
What is the FDA product code for LOGIQ E10?
The FDA product code for LOGIQ E10 is IYN.
Other Devices by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
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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.