FDA · official record K133406Substantially Equivalent

CS 8100 3D

Name: CS 8100 3D — FDA K133406
Creator: Trophy
Keywords: CS 8100 3D, CS 8100 3D, K133406, OAS, FDA

United StatesOASTrophy

Verified

Official record identity

FDA application number: K133406
Decision date: March 14, 2014
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Trophy

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2013-11-06
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.