Device Classification Name |
Oximeter
|
510(k) Number |
K921454 |
Device Name |
FUKUDA DENSHI MODEL HG-301 |
Applicant |
FUKUDA DENSHI USA, INC. |
7102-A 180TH AVENUE NORTHEAST |
REDMOND,
WA
98052
|
|
Applicant Contact |
ROBERT STEURER |
Correspondent |
FUKUDA DENSHI USA, INC. |
7102-A 180TH AVENUE NORTHEAST |
REDMOND,
WA
98052
|
|
Correspondent Contact |
ROBERT STEURER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/26/1992 |
Decision Date | 04/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|