LOGIQ V1/ LOGIQ V2
K-Number: K153037 · 2016-01-04
Decision Date2016-01-04
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LOGIQ V1/ LOGIQ V2 is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2016-01-04 under approval number K153037. 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 V1/ LOGIQ V2?
LOGIQ V1/ LOGIQ V2 is a medical device that received FDA 510(k) clearance on 2016-01-04. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K153037.
When was LOGIQ V1/ LOGIQ V2 approved by the FDA?
LOGIQ V1/ LOGIQ V2 received FDA 510(k) clearance on 2016-01-04, under approval number K153037.
What company makes LOGIQ V1/ LOGIQ V2?
LOGIQ V1/ LOGIQ V2 is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.
What is the FDA product code for LOGIQ V1/ LOGIQ V2?
The FDA product code for LOGIQ V1/ LOGIQ V2 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.