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 Number | 892.1830
|
Classification Product Code |
|
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
|
|
|