FDA 510(k)

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE

K-Number: K031001 · 2003-05-21

Decision Date2003-05-21

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2003-05-21 under 510(k) number K031001. 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 ACMI VISTA CTR BIPOLAR LOOP ELECTRODE?

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE is a medical device that received FDA 510(k) clearance on 2003-05-21. The listed applicant is Acmi Corporation. The 510(k) number is K031001.

When did ACMI VISTA CTR BIPOLAR LOOP ELECTRODE receive FDA 510(k) clearance?

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE received FDA 510(k) clearance on 2003-05-21, under 510(k) number K031001.

Who is the listed applicant for ACMI VISTA CTR BIPOLAR LOOP ELECTRODE?

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 VISTA CTR BIPOLAR LOOP ELECTRODE?

The FDA product code for ACMI VISTA CTR BIPOLAR LOOP 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.