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FDA 510(k)

GC Temp Print

K-Number: K193113 · 2020-07-09

ApplicantGC America, Inc.
Decision Date2020-07-09
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC Temp Print is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2020-07-09 under approval number K193113. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC Temp Print?

GC Temp Print is a medical device that received FDA 510(k) clearance on 2020-07-09. It is manufactured by GC America, Inc.. The 510(k) number is K193113.

When was GC Temp Print approved by the FDA?

GC Temp Print received FDA 510(k) clearance on 2020-07-09, under approval number K193113.

What company makes GC Temp Print?

GC Temp Print is manufactured by GC America, Inc..

What is the FDA product code for GC Temp Print?

The FDA product code for GC Temp Print is EBG.

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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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