FDA · official record K954565Substantially Equivalent

EXPLOR-X (AZTEH) HF

Name: EXPLOR-X (AZTEH) HF — FDA K954565
Creator: Chicago X-Ray Systems, Inc.
Keywords: EXPLOR-X (AZTEH) HF, EXPLOR-X (AZTEH) HF, K954565, EAP, FDA

United StatesEAPChicago X-Ray Systems, Inc.

Verified

Official record identity

FDA application number: K954565
Decision date: October 27, 1995
Published decision: Substantially Equivalent

Classification

Product code: EAP

Published parties

Applicant: Chicago X-Ray Systems, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1995-10-02
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1810

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.