Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K100928 |
Device Name |
MICRO DIARY SPIROMETER |
Applicant |
VIASYS RESPIRATORY CARE INC. |
22745 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Applicant Contact |
MERRITT GIRGIS |
Correspondent |
VIASYS RESPIRATORY CARE INC. |
22745 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Correspondent Contact |
MERRITT GIRGIS |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 04/05/2010 |
Decision Date | 03/07/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|