ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES— 510(k) K043325

Name: FDA 510(k) clearance K043325
Creator: U.S. Food and Drug Administration
Published: 2005-02-11

Substantially Equivalent

Rolence Enteprise, Inc.

FDA 510(k) clearance K043325 for ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES, Substantially Equivalent on 2005-02-11. Applicant: Rolence Enteprise, Inc.. Device class: 1.

Clearance details

Applicant: Rolence Enteprise, Inc.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2004-12-02
Decision date: 2005-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chungi, TW

Download summary PDF View on FDA.gov ↗

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