ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM— 510(k) K041834

Name: FDA 510(k) clearance K041834
Creator: U.S. Food and Drug Administration
Published: 2004-12-03

Substantially Equivalent

Takara Belmont USA, Inc.

FDA 510(k) clearance K041834 for ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM, Substantially Equivalent on 2004-12-03. Applicant: Takara Belmont USA, Inc.. Device class: 2.

Clearance details

Applicant: Takara Belmont USA, Inc.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2004-07-07
Decision date: 2004-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

Download summary PDF View on FDA.gov ↗

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