Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K043528 |
Device Name |
SPIROTEL |
Applicant |
MIR MEDICAL INTL. RESEARCH SRL |
VIA DEL MAGGIOLINO 125 |
ROMA,
IT
00155
|
|
Applicant Contact |
SIMON FOWLER |
Correspondent |
MIR MEDICAL INTL. RESEARCH SRL |
VIA DEL MAGGIOLINO 125 |
ROMA,
IT
00155
|
|
Correspondent Contact |
SIMON FOWLER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/21/2004 |
Decision Date | 07/19/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|