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FDA 510(k)

LOGIQ P10, LOGIQ P9, LOGIQ P8

K-Number: K214039 · 2022-03-22

Decision Date2022-03-22
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LOGIQ P10, LOGIQ P9, LOGIQ P8 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2022-03-22 under approval number K214039. 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 P10, LOGIQ P9, LOGIQ P8?

LOGIQ P10, LOGIQ P9, LOGIQ P8 is a medical device that received FDA 510(k) clearance on 2022-03-22. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K214039.

When was LOGIQ P10, LOGIQ P9, LOGIQ P8 approved by the FDA?

LOGIQ P10, LOGIQ P9, LOGIQ P8 received FDA 510(k) clearance on 2022-03-22, under approval number K214039.

What company makes LOGIQ P10, LOGIQ P9, LOGIQ P8?

LOGIQ P10, LOGIQ P9, LOGIQ P8 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

What is the FDA product code for LOGIQ P10, LOGIQ P9, LOGIQ P8?

The FDA product code for LOGIQ P10, LOGIQ P9, LOGIQ P8 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.