FDA · official record K081237Substantially Equivalent

CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT

Name: CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT — FDA K081237
Creator: Craftmaster Contour Equipment, Inc.
Keywords: CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT, CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT, K081237, EIA, FDA

United StatesEIACraftmaster Contour Equipment, Inc.

Verified

Official record identity

FDA application number: K081237
Decision date: August 25, 2008
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Craftmaster Contour Equipment, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2008-05-01
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

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.