ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D— 510(k) K043612

Name: FDA 510(k) clearance K043612
Creator: U.S. Food and Drug Administration
Published: 2005-02-09

Substantially Equivalent

Instrumentarium Corp. Imaging Division

FDA 510(k) clearance K043612 for ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D, Substantially Equivalent on 2005-02-09. Applicant: Instrumentarium Corp. Imaging Division. Device class: 2.

Clearance details

Applicant: Instrumentarium Corp. Imaging Division
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2004-12-30
Decision date: 2005-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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