Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
510(k) Number |
K911344 |
Device Name |
CERION HAND HELD OXYGEN ANALYZER |
Applicant |
CERAMATEC, INC. |
2425 SOUTH 900 WEST |
SALT LAKE CITY,
UT
84119
|
|
Applicant Contact |
MARK HASLAM |
Correspondent |
CERAMATEC, INC. |
2425 SOUTH 900 WEST |
SALT LAKE CITY,
UT
84119
|
|
Correspondent Contact |
MARK HASLAM |
Regulation Number | 868.1720
|
Classification Product Code |
|
Date Received | 03/27/1991 |
Decision Date | 06/18/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|