FDA 510(k)

FUJI DUET

K-Number: K946100 · 1995-01-20

Decision Date1995-01-20

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FUJI DUET 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 1995-01-20 under 510(k) number K946100. 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 DUET?

FUJI DUET is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is GC America, Inc.. The 510(k) number is K946100.

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

FUJI DUET received FDA 510(k) clearance on 1995-01-20, under 510(k) number K946100.

Who is the listed applicant for FUJI DUET?

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 DUET?

The FDA product code for FUJI DUET 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.