SPEEDER 1.5T WRIST ARRAY COIL— 510(k) K072935

Substantially Equivalent

Quality Electrodynamics

FDA 510(k) clearance K072935 for SPEEDER 1.5T WRIST ARRAY COIL, Substantially Equivalent on 2007-10-31. Applicant: Quality Electrodynamics. Device class: 2.

Clearance details

Applicant
Quality Electrodynamics
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
Mayfield Village, OH, US
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