Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K032063 |
Device Name |
PEM 2400 PET SCANNER |
Applicant |
PEM TECHNOLOGIES |
7617 STANDISH PLACE |
ROCKVILLE,
MD
20855
|
|
Applicant Contact |
IRVING WEINBERG |
Correspondent |
PEM TECHNOLOGIES |
7617 STANDISH PLACE |
ROCKVILLE,
MD
20855
|
|
Correspondent Contact |
IRVING WEINBERG |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 07/03/2003 |
Decision Date | 08/18/2003 |
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
|
|
|