CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES— 510(k) K061175

Name: FDA 510(k) clearance K061175
Creator: U.S. Food and Drug Administration
Published: 2006-05-23

Substantially Equivalent

Sota Precision Optics, Inc.

FDA 510(k) clearance K061175 for CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES, Substantially Equivalent on 2006-05-23. Applicant: Sota Precision Optics, Inc.. Device class: 1.

Clearance details

Applicant: Sota Precision Optics, Inc.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2006-04-27
Decision date: 2006-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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