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FDA 510(k)

LOGIQ P9 and LOGIQ P7

K-Number: K161047 · 2016-05-05

ApplicantGE Healthcare
Decision Date2016-05-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LOGIQ P9 and LOGIQ P7 is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2016-05-05 under approval number K161047. 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 and LOGIQ P7?

LOGIQ P9 and LOGIQ P7 is a medical device that received FDA 510(k) clearance on 2016-05-05. It is manufactured by GE Healthcare. The 510(k) number is K161047.

When was LOGIQ P9 and LOGIQ P7 approved by the FDA?

LOGIQ P9 and LOGIQ P7 received FDA 510(k) clearance on 2016-05-05, under approval number K161047.

What company makes LOGIQ P9 and LOGIQ P7?

LOGIQ P9 and LOGIQ P7 is manufactured by GE Healthcare.

What is the FDA product code for LOGIQ P9 and LOGIQ P7?

The FDA product code for LOGIQ P9 and 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.

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