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FDA 510(k)

LOGIQ E10s, LOGIQ Fortis

K-Number: K211524 · 2021-08-27

ApplicantGE Healthcare
Decision Date2021-08-27
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LOGIQ E10s, LOGIQ Fortis is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2021-08-27 under approval number K211524. 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 2021-08-27. It is manufactured by GE Healthcare. The 510(k) number is K211524.

When was LOGIQ E10s, LOGIQ Fortis approved by the FDA?

LOGIQ E10s, LOGIQ Fortis received FDA 510(k) clearance on 2021-08-27, under approval number K211524.

What company makes LOGIQ E10s, LOGIQ Fortis?

LOGIQ E10s, LOGIQ Fortis is manufactured by GE Healthcare.

What is the FDA product code for LOGIQ E10s, LOGIQ Fortis?

The FDA product code for LOGIQ E10s, LOGIQ Fortis 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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