UNICORN MODEL SYS0630— 510(k) K001888

Name: FDA 510(k) clearance K001888
Creator: U.S. Food and Drug Administration
Published: 2000-06-30

Substantially Equivalent

Danish Diagnostic Development A/S

FDA 510(k) clearance K001888 for UNICORN MODEL SYS0630, Substantially Equivalent on 2000-06-30. Applicant: Danish Diagnostic Development A/S. Device class: 2.

Clearance details

Applicant: Danish Diagnostic Development A/S
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2000-06-15
Decision date: 2000-06-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: 2970 Horshom, DK

Download summary PDF View on FDA.gov ↗

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