Device Classification Name |
Gas, Calibration (Specified Concentration)
|
510(k) Number |
K935311 |
Device Name |
CLINICAL BLOOD GAS |
Applicant |
ACETYLENE GAS CO. |
3500 BERNARD |
ST. LOUIS,
MO
63103
|
|
Applicant Contact |
KRIS LUTHER |
Correspondent |
ACETYLENE GAS CO. |
3500 BERNARD |
ST. LOUIS,
MO
63103
|
|
Correspondent Contact |
KRIS LUTHER |
Regulation Number | 868.6400
|
Classification Product Code |
|
Date Received | 11/02/1993 |
Decision Date | 12/22/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|