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FDA 510(k)

GC Fuji Triage EP

K-Number: K193484 · 2020-07-02

ApplicantGC America, Inc.
Decision Date2020-07-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC Fuji Triage EP 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 2020-07-02 under 510(k) number K193484. 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 GC Fuji Triage EP?

GC Fuji Triage EP is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is GC America, Inc.. The 510(k) number is K193484.

When did GC Fuji Triage EP receive FDA 510(k) clearance?

GC Fuji Triage EP received FDA 510(k) clearance on 2020-07-02, under 510(k) number K193484.

Who is the listed applicant for GC Fuji Triage EP?

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 GC Fuji Triage EP?

The FDA product code for GC Fuji Triage EP is EMA.

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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