Device Classification Name |
Oximeter
|
510(k) Number |
K011974 |
Device Name |
SENSAID |
Applicant |
SENSIDYNE, INC. |
16333 BAY VISTA DR. |
CLEARWATER,
FL
33760
|
|
Applicant Contact |
GEORGE MASON |
Correspondent |
SENSIDYNE, INC. |
16333 BAY VISTA DR. |
CLEARWATER,
FL
33760
|
|
Correspondent Contact |
GEORGE MASON |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 06/25/2001 |
Decision Date | 02/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|