Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
510(k) Number |
K894918 |
Device Name |
HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. |
Applicant |
MENNEN MEDICAL, INC. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Applicant Contact |
RICHARD WHITEHEAD |
Correspondent |
MENNEN MEDICAL, INC. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Correspondent Contact |
RICHARD WHITEHEAD |
Regulation Number | 868.1720
|
Classification Product Code |
|
Date Received | 08/02/1989 |
Decision Date | 10/31/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|