Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K904200 |
Device Name |
SPIROSIFT 500A |
Applicant |
FUKUDA DENSHI USA, INC. |
7102-A 180TH AVENUE NORTHEAST |
REDMOND,
WA
98052
|
|
Applicant Contact |
ROBERT J STEURER |
Correspondent |
FUKUDA DENSHI USA, INC. |
7102-A 180TH AVENUE NORTHEAST |
REDMOND,
WA
98052
|
|
Correspondent Contact |
ROBERT J STEURER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 09/12/1990 |
Decision Date | 05/22/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|