LOGIQ E10s, LOGIQ Fortis
K-Number: K231989 · 2023-11-07
Decision Date2023-11-07
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LOGIQ E10s, LOGIQ Fortis is a medical device manufactured by Ge Medical Systems Ultrasound and Primary Care Diagnostic,. It received FDA 510(k) clearance on 2023-11-07 under approval number K231989. 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 E10s, LOGIQ Fortis?
LOGIQ E10s, LOGIQ Fortis is a medical device that received FDA 510(k) clearance on 2023-11-07. It is manufactured by Ge Medical Systems Ultrasound and Primary Care Diagnostic,. The 510(k) number is K231989.
When was LOGIQ E10s, LOGIQ Fortis approved by the FDA?
LOGIQ E10s, LOGIQ Fortis received FDA 510(k) clearance on 2023-11-07, under approval number K231989.
What company makes LOGIQ E10s, LOGIQ Fortis?
LOGIQ E10s, LOGIQ Fortis is manufactured by Ge Medical Systems Ultrasound and Primary Care Diagnostic,.
What is the FDA product code for LOGIQ E10s, LOGIQ Fortis?
The FDA product code for LOGIQ E10s, LOGIQ Fortis is IYN.
Other Devices by Ge Medical Systems Ultrasound and Primary Care Diagnostic,
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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.