FDA 510(k)

FUJI II

K-Number: K980682 · 1998-04-03

Decision Date1998-04-03

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FUJI II is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 1998-04-03 under 510(k) number K980682. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJI II?

FUJI II is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is GC America, Inc.. The 510(k) number is K980682.

When did FUJI II receive FDA 510(k) clearance?

FUJI II received FDA 510(k) clearance on 1998-04-03, under 510(k) number K980682.

Who is the listed applicant for FUJI II?

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

What is the FDA product code for FUJI II?

The FDA product code for FUJI II is EMA.

Other records listing GC America, Inc. as applicant

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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.