FDA 510(k)

GYRUS AMCI PK BUTTON ELECTRODE

K-Number: K120567 · 2012-06-20

Decision Date2012-06-20

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

GYRUS AMCI PK BUTTON ELECTRODE 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 2012-06-20 under 510(k) number K120567. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS AMCI PK BUTTON ELECTRODE?

GYRUS AMCI PK BUTTON ELECTRODE is a medical device that received FDA 510(k) clearance on 2012-06-20. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K120567.

When did GYRUS AMCI PK BUTTON ELECTRODE receive FDA 510(k) clearance?

GYRUS AMCI PK BUTTON ELECTRODE received FDA 510(k) clearance on 2012-06-20, under 510(k) number K120567.

Who is the listed applicant for GYRUS AMCI PK BUTTON ELECTRODE?

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 GYRUS AMCI PK BUTTON ELECTRODE?

The FDA product code for GYRUS AMCI PK BUTTON ELECTRODE is FAS.

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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.