Device Classification Name |
densitometer, bone
|
510(k) Number |
K072439 |
Device Name |
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT |
Applicant |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
726 HEARTLAND TRAIL |
MADISON,
WI
53717
|
|
Applicant Contact |
JAMES P RASKOB |
Correspondent |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
726 HEARTLAND TRAIL |
MADISON,
WI
53717
|
|
Correspondent Contact |
JAMES P RASKOB |
Regulation Number | 892.1170
|
Classification Product Code |
|
Date Received | 08/30/2007 |
Decision Date | 09/14/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|