FDA 510(k)

iSMILE

K号: K200908 · 2020-12-22

决定日期2020-12-22

产品代码NXC

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决定实质等同

器械摘要

iSMILE is the device name listed in this FDA 510(k) record. The listed applicant is 3D Diagnostix, Inc.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K200908. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iSMILE?

iSMILE is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is 3D Diagnostix, Inc.. The 510(k) number is K200908.

When did iSMILE receive FDA 510(k) clearance?

iSMILE received FDA 510(k) clearance on 2020-12-22, under 510(k) number K200908.

Who is the listed applicant for iSMILE?

The FDA 510(k) record lists 3D Diagnostix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iSMILE?

The FDA product code for iSMILE is NXC.

列明3D Diagnostix, Inc.为申报人的其他记录

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