Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K943546 |
Device Name |
FUKUDA SANGYO MODEL SPIROANALYZER ST-180 |
Applicant |
SPIROSOFT NORTHAMERICA, INC. |
2522 CHAMBERS RD. |
SUTIE 110-B |
TUSTIN,
CA
92680
|
|
Applicant Contact |
RAYMOND W COHEN |
Correspondent |
SPIROSOFT NORTHAMERICA, INC. |
2522 CHAMBERS RD. |
SUTIE 110-B |
TUSTIN,
CA
92680
|
|
Correspondent Contact |
RAYMOND W COHEN |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 07/21/1994 |
Decision Date | 02/23/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|