PEDIATRIC POSITIONER PAD SET


Device Classification Name

cradle, patient, radiologic

510(k) Number K122174
Device Name PEDIATRIC POSITIONER PAD SET
Applicant
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
1515 danner dr
aurora, 
OH 
44202 -9273

Applicant Contact michelle huettner
Correspondent
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
1515 danner dr
aurora, 
OH 
44202 -9273

Correspodent Contact michelle huettner
Regulation Number 892.1830
Classification Product Code
KXH  
Date Received 07/23/2012
Decision Date 11/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No