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FDA 510(k)

PK AIM

K-Number: K161825 · 2016-09-26

ApplicantGyrus Acmi, Inc.
Decision Date2016-09-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PK AIM is a medical device manufactured by Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2016-09-26 under approval number K161825. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PK AIM?

PK AIM is a medical device that received FDA 510(k) clearance on 2016-09-26. It is manufactured by Gyrus Acmi, Inc.. The 510(k) number is K161825.

When was PK AIM approved by the FDA?

PK AIM received FDA 510(k) clearance on 2016-09-26, under approval number K161825.

What company makes PK AIM?

PK AIM is manufactured by Gyrus Acmi, Inc..

What is the FDA product code for PK AIM?

The FDA product code for PK AIM is GEI.

Other Devices by Gyrus Acmi, Inc.

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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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