FDA 510(k), K173244, superDimension Navigation System V7.2
FDA 510(k), K173244, superDimension Navigation System V7.2
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510(K) Number: K173244
Device Name: superDimension Navigation System V7.2
Manufacturer: Covidien LLC
Device Classification Name: system, x-ray, tomography, computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 10/06/2017
Decision Date: 02/08/2018
Regulation Medical Specialty: Radiology
563 pages (1,812 of 2,375 original pages are fully redacted)