HAWK INTRAORAL CAMERA AND ACCESSORIES— 510(k) K040116

Name: FDA 510(k) clearance K040116
Creator: U.S. Food and Drug Administration
Published: 2004-04-20

Substantially Equivalent

Dxm Co., Ltd.

FDA 510(k) clearance K040116 for HAWK INTRAORAL CAMERA AND ACCESSORIES, Substantially Equivalent on 2004-04-20. Applicant: Dxm Co., Ltd.. Device class: 1.

Clearance details

Applicant: Dxm Co., Ltd.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2004-01-20
Decision date: 2004-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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