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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact MICHELLE HUETTNER
Regulation Number892.1830
Classification Product Code
KXH  
Date Received07/23/2012
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
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