CYCLONE, MODEL MAICAM 180— 510(k) K060486

Substantially Equivalent

Spectrica

FDA 510(k) clearance K060486 for CYCLONE, MODEL MAICAM 180, Substantially Equivalent on 2006-03-23. Applicant: Spectrica. Device class: 2.

Clearance details

Applicant: Spectrica
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2006-02-24
Decision date: 2006-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, Ontario, CA

Download summary PDF View on FDA.gov ↗

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