MACHNET CAROTIDS COIL ARRAY ASSEMBLY— 510(k) K012491

Substantially Equivalent

Machnet BV

FDA 510(k) clearance K012491 for MACHNET CAROTIDS COIL ARRAY ASSEMBLY, Substantially Equivalent on 2001-10-24. Applicant: Machnet BV. Device class: 2.

Clearance details

Applicant
Machnet BV
Product code
Code MOS
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Deer Field, IL, US
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