FDA 510(k)

ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

K-Number: K042225 · 2004-09-10

Decision Date2004-09-10

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2004-09-10 under 510(k) number K042225. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565?

ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 is a medical device that received FDA 510(k) clearance on 2004-09-10. The listed applicant is Acmi Corporation. The 510(k) number is K042225.

When did ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 receive FDA 510(k) clearance?

ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 received FDA 510(k) clearance on 2004-09-10, under 510(k) number K042225.

Who is the listed applicant for ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565?

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

What is the FDA product code for ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565?

The FDA product code for ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 is FAJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.