FDA · official record K965203Substantially Equivalent

RADX SYSTEM

Name: RADX SYSTEM — FDA K965203
Creator: Electro Medical Systems, Inc.
Keywords: RADX SYSTEM, RADX SYSTEM, K965203, EHD, FDA

United StatesEHDElectro Medical Systems, Inc.

Verified

Official record identity

FDA application number: K965203
Decision date: March 17, 1997
Published decision: Substantially Equivalent

Classification

Product code: EHD

Published parties

Applicant: Electro Medical Systems, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-12-26
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

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.