Device Classification Name |
probe, uptake, nuclear
|
510(k) Number |
K013751 |
Device Name |
HANDHELD GAMMA FINDER (HGF) |
Applicant |
SILICON INSTRUMENTS GMHB |
OSTENDSTRASSE 1 |
BERLIN,
DE
D-12459
|
|
Applicant Contact |
THOMAS GOEBEL |
Correspondent |
SILICON INSTRUMENTS GMHB |
OSTENDSTRASSE 1 |
BERLIN,
DE
D-12459
|
|
Correspondent Contact |
THOMAS GOEBEL |
Regulation Number | 892.1320
|
Classification Product Code |
|
Date Received | 11/13/2001 |
Decision Date | 02/06/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|