DIGORA— 510(k) K934949

Substantially Equivalent

Orion Corporation Soredex

FDA 510(k) clearance K934949 for DIGORA, Substantially Equivalent on 1994-02-10. Applicant: Orion Corporation Soredex. Device class: 2.

Clearance details

Applicant: Orion Corporation Soredex
Product code: Code IXK
Device class: Class 2
Regulation: 21 CFR 892.1630
Advisory panel: Radiology
Date received: 1993-10-18
Decision date: 1994-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.