HFO SHOULDER COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K080120
Device Name HFO SHOULDER COIL
Applicant
PHILIPS MEDICAL SYSTEMS MR FINLAND
595 miner road
cleveland, 
OH 
44143

Applicant Contact catherine connell
Correspondent
PHILIPS MEDICAL SYSTEMS MR FINLAND
595 miner road
cleveland, 
OH 
44143

Correspodent Contact catherine connell
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 01/17/2008
Decision Date 03/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No