Device Classification Name |
Densitometer, Bone
|
510(k) Number |
K041266 |
Device Name |
PEDIATRIC REFERENCE DATABASE |
Applicant |
HOLOGIC, INC. |
35 CROSBY DR. |
BEDFORD,
MA
01730
|
|
Applicant Contact |
ANA RANDALL |
Correspondent |
HOLOGIC, INC. |
35 CROSBY DR. |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
ANA RANDALL |
Regulation Number | 892.1170
|
Classification Product Code |
|
Date Received | 05/12/2004 |
Decision Date | 08/11/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|