Device Classification Name |
calibrator, dose, radionuclide
|
510(k) Number |
K090296 |
Device Name |
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 |
Applicant |
BIODEX MEDICAL SYSTEMS, INC. |
20 RAMSAY RD. |
SHIRLEY,
NY
11967
|
|
Applicant Contact |
CLYDE SCHLEIN |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
JAY Y KOGOMA |
Regulation Number | 892.1360
|
Classification Product Code |
|
Date Received | 02/06/2009 |
Decision Date | 02/19/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|