Device Classification Name |
oximeter
|
510(k) Number |
K863857 |
Device Name |
PULSE-OX |
Applicant |
LIFE DESIGN SYSTEMS, INC. |
2735 EAST BELT LINE RD. |
CARROLLTON,
TX
75006
|
|
Applicant Contact |
GILBERT M KIRK |
Correspondent |
LIFE DESIGN SYSTEMS, INC. |
2735 EAST BELT LINE RD. |
CARROLLTON,
TX
75006
|
|
Correspondent Contact |
GILBERT M KIRK |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 10/02/1986 |
Decision Date | 10/07/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|