MILLENNIUM 5000 MEUROVASCULAR COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K021141
Device Name MILLENNIUM 5000 MEUROVASCULAR COIL
Original Applicant
USA INSTRUMENTS, INC.
1515 danner dr.
aurora, 
OH 
44202

Original Contact christie shumaker
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 04/09/2002
Decision Date 06/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No