FDA · official record K043068Substantially Equivalent

DIFOTI USB 2.0 SYSTEM

Name: DIFOTI USB 2.0 SYSTEM — FDA K043068
Creator: Electro-Optical Sciences, Inc.
Keywords: DIFOTI USB 2.0 SYSTEM, DIFOTI USB 2.0 SYSTEM, K043068, NTK, FDA

United StatesNTKElectro-Optical Sciences, Inc.

Verified

Official record identity

FDA application number: K043068
Decision date: December 29, 2004
Published decision: Substantially Equivalent

Classification

Product code: NTK

Published parties

Applicant: Electro-Optical Sciences, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2004-11-08
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1745

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.