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FDA 510(k)

AIM2

K-Number: K181011 · 2018-07-12

ApplicantGC America, Inc.
Decision Date2018-07-12
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIM2 is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2018-07-12 under approval number K181011. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIM2?

AIM2 is a medical device that received FDA 510(k) clearance on 2018-07-12. It is manufactured by GC America, Inc.. The 510(k) number is K181011.

When was AIM2 approved by the FDA?

AIM2 received FDA 510(k) clearance on 2018-07-12, under approval number K181011.

What company makes AIM2?

AIM2 is manufactured by GC America, Inc..

What is the FDA product code for AIM2?

The FDA product code for AIM2 is ELW.

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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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