Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K894556 |
Device Name |
SPIROTEQ |
Applicant |
SYSTEM ANALYSIS CORP. |
ZONE INDUSTRIELLE - 13 BIS, |
RUE DES DAMES - 78340 LES |
CLAYES SOUS BOIS, FRANCE,
FR
|
|
Applicant Contact |
VERONIQUE BREIER |
Correspondent |
SYSTEM ANALYSIS CORP. |
ZONE INDUSTRIELLE - 13 BIS, |
RUE DES DAMES - 78340 LES |
CLAYES SOUS BOIS, FRANCE,
FR
|
|
Correspondent Contact |
VERONIQUE BREIER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 07/20/1989 |
Decision Date | 01/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|