Device Classification Name |
analyzer, gas, oxygen, gaseous-phase
|
510(k) Number |
K941793 |
Device Name |
OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) |
Applicant |
MOUNTAIN MEDICAL EQUIPMENT, INC. |
10488 WEST CENTENNIAL RD. |
LITTLETON,
CO
80127
|
|
Applicant Contact |
LINDA CHAPMAN |
Correspondent |
MOUNTAIN MEDICAL EQUIPMENT, INC. |
10488 WEST CENTENNIAL RD. |
LITTLETON,
CO
80127
|
|
Correspondent Contact |
LINDA CHAPMAN |
Regulation Number | 868.1720
|
Classification Product Code |
|
Date Received | 04/11/1994 |
Decision Date | 06/21/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|