BIO-RAY SDX DIGITAL X-RAY SYSTEM— 510(k) K060179

Substantially Equivalent

Sigma Biomedics, Inc.

FDA 510(k) clearance K060179 for BIO-RAY SDX DIGITAL X-RAY SYSTEM, Substantially Equivalent on 2006-02-08. Applicant: Sigma Biomedics, Inc..

Clearance details

Applicant: Sigma Biomedics, Inc.
Product code: Code MUH
Advisory panel: Dental
Date received: 2006-01-23
Decision date: 2006-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prospect Heights, IL, US

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