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FDA 510(k)

PK AIM

K-Number: K163373 · 2016-12-12

ApplicantGyrus Acmi, Inc.
Decision Date2016-12-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PK AIM is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K163373. 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 2016-12-12. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K163373.

When did PK AIM receive FDA 510(k) clearance?

PK AIM received FDA 510(k) clearance on 2016-12-12, under 510(k) number K163373.

Who is the listed applicant for PK AIM?

The FDA 510(k) record lists Gyrus Acmi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PK AIM?

The FDA product code for PK AIM is GEI.

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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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