Device Classification Name |
Electrode, Ion Specific, Potassium
|
510(k) Number |
K061107 |
Device Name |
DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 |
Applicant |
THERMO ELECTRON OY |
RATASTIE 2 |
VANTAA,
FI
01620
|
|
Applicant Contact |
PAIVI SORMUNEN |
Correspondent |
THERMO ELECTRON OY |
RATASTIE 2 |
VANTAA,
FI
01620
|
|
Correspondent Contact |
PAIVI SORMUNEN |
Regulation Number | 862.1600
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/20/2006 |
Decision Date | 08/08/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|