Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K983909 |
Device Name |
MIR SPIROBANK SPIROMETER |
Applicant |
MIR MEDICAL INTL. RESEARCH SRL |
VICOLO MADDALENA 22/A |
ALBANO LAZIALE, ROMA,
IT
00041
|
|
Applicant Contact |
SIMON FOWLER |
Correspondent |
MIR MEDICAL INTL. RESEARCH SRL |
VICOLO MADDALENA 22/A |
ALBANO LAZIALE, ROMA,
IT
00041
|
|
Correspondent Contact |
SIMON FOWLER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 11/03/1998 |
Decision Date | 12/21/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|