SPIRIT III TOTALSENSE CARDIAC COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K024187
Device Name SPIRIT III TOTALSENSE CARDIAC 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 12/19/2002
Decision Date 02/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No