Device Classification Name |
oximeter
|
510(k) Number |
K873896 |
Device Name |
SIMED S-100 PULSE OXIMETER |
Applicant |
SIMED |
11818 NORTHCREEK PARKWAY N. |
BOTHELL,
WA
98011
|
|
Applicant Contact |
LAU, MD |
Correspondent |
SIMED |
11818 NORTHCREEK PARKWAY N. |
BOTHELL,
WA
98011
|
|
Correspondent Contact |
LAU, MD |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/02/1987 |
Decision Date | 03/07/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|