Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K984031 |
Device Name |
SPIROVIT, MODEL SP-250 |
Applicant |
SCHILLER AG |
ALTGASSE 68 |
BAAR,
CH
CH-6341
|
|
Applicant Contact |
MARKUS BUETLER |
Correspondent |
SCHILLER AG |
ALTGASSE 68 |
BAAR,
CH
CH-6341
|
|
Correspondent Contact |
MARKUS BUETLER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 11/12/1998 |
Decision Date | 04/30/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|