FDA · official record K000061Substantially Equivalent

MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT

Name: MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT — FDA K000061
Creator: Minxray, Inc.
Keywords: MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT, MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT, K000061, EHD, FDA

United StatesEHDMinxray, Inc.

Verified

Official record identity

FDA application number: K000061
Decision date: April 07, 2000
Published decision: Substantially Equivalent

Classification

Product code: EHD

Published parties

Applicant: Minxray, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2000-01-10
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.