Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K897094 |
Device Name |
MODIFIED SPIROSCAN 1000 |
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 | 12/20/1989 |
Decision Date | 01/12/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|