LOGIQ P9; LOGIQ P7
K-Number: K181783 · 2018-09-20
ApplicantGE Healthcare
Decision Date2018-09-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LOGIQ P9; LOGIQ P7 is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2018-09-20 under approval number K181783. 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 P9; LOGIQ P7?
LOGIQ P9; LOGIQ P7 is a medical device that received FDA 510(k) clearance on 2018-09-20. It is manufactured by GE Healthcare. The 510(k) number is K181783.
When was LOGIQ P9; LOGIQ P7 approved by the FDA?
LOGIQ P9; LOGIQ P7 received FDA 510(k) clearance on 2018-09-20, under approval number K181783.
What company makes LOGIQ P9; LOGIQ P7?
LOGIQ P9; LOGIQ P7 is manufactured by GE Healthcare.
What is the FDA product code for LOGIQ P9; LOGIQ P7?
The FDA product code for LOGIQ P9; LOGIQ P7 is IYN.
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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.