Device Classification Name |
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
|
510(k) Number |
K832779 |
Device Name |
REFEREE BLOOD GAS ANALYZER-ELECTRODES |
Applicant |
ANALYTICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ANALYTICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1120 |
Classification Product Code |
|
Date Received | 08/16/1983 |
Decision Date | 10/14/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|