FDA 510(k)

COE SOFT

K-Number: K070697 · 2007-03-29

Decision Date2007-03-29

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

COE SOFT 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 2007-03-29 under 510(k) number K070697. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COE SOFT?

COE SOFT is a medical device that received FDA 510(k) clearance on 2007-03-29. The listed applicant is GC America, Inc.. The 510(k) number is K070697.

When did COE SOFT receive FDA 510(k) clearance?

COE SOFT received FDA 510(k) clearance on 2007-03-29, under 510(k) number K070697.

Who is the listed applicant for COE SOFT?

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 COE SOFT?

The FDA product code for COE SOFT is EBI.

Other records listing GC America, Inc. as applicant

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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.