SPIRIT 5000 CARDIAC COIL

Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K033490
Device Name SPIRIT 5000 CARDIAC COIL
Applicant
USA INSTRUMENTS, INC.
1515 danner dr.
aurora, 
OH 
44202

Applicant Contact christie shumaker
Correspondent
USA INSTRUMENTS, INC.
1515 danner dr.
aurora, 
OH 
44202

Correspodent Contact christie shumaker
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 11/04/2003
Decision Date 01/09/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No