Device Classification Name |
electrode measurement, blood-gases (pco2, po2) and blood ph
|
510(k) Number |
K821483 |
Device Name |
IL 1302 PH BLOOD GAS ANALYZER |
Applicant |
INSTRUMENTATION LABORATORY CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
INSTRUMENTATION LABORATORY CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1120
|
Classification Product Code |
|
Date Received | 05/18/1982 |
Decision Date | 06/10/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|