SCINTILLATION GAMMA CAMERA— 510(k) K140206

Substantially Equivalent

Ddd-Diagnostic A/S

FDA 510(k) clearance K140206 for SCINTILLATION GAMMA CAMERA, Substantially Equivalent on 2014-05-08. Applicant: Ddd-Diagnostic A/S. Device class: 2.

Clearance details

Applicant: Ddd-Diagnostic A/S
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2014-01-27
Decision date: 2014-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, 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.