Device Classification Name |
Electrode, Ion Specific, Potassium
|
510(k) Number |
K897110 |
Device Name |
SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM |
Applicant |
MEDISENSE, INC. |
128 SIDNEY ST. |
CAMBRIDGE,
MA
02139
|
|
Applicant Contact |
LIAS, PH.D. |
Correspondent |
MEDISENSE, INC. |
128 SIDNEY ST. |
CAMBRIDGE,
MA
02139
|
|
Correspondent Contact |
LIAS, PH.D. |
Regulation Number | 862.1600
|
Classification Product Code |
|
Date Received | 12/26/1989 |
Decision Date | 02/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|