Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K103530 |
Device Name |
SPIRODOC |
Applicant |
MEDICAL INTERNATIONAL RESEARCH USA, INC. |
1900 PEWAUKEE ROAD |
SUITE O |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
ED KOHERE |
Correspondent |
MEDICAL INTERNATIONAL RESEARCH USA, INC. |
1900 PEWAUKEE ROAD |
SUITE O |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
ED KOHERE |
Regulation Number | 868.1840
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/01/2010 |
Decision Date | 11/21/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|