Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K073155 |
Device Name |
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) |
Applicant |
VITALOGRAPH(IRELAND) LTD. |
ENNIS INDUSTRIAL ESTATE |
GORT ROAD |
ENNIS, CO. CLARE,
IE
|
|
Applicant Contact |
TOM J HEALY |
Correspondent |
VITALOGRAPH(IRELAND) LTD. |
ENNIS INDUSTRIAL ESTATE |
GORT ROAD |
ENNIS, CO. CLARE,
IE
|
|
Correspondent Contact |
TOM J HEALY |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 11/08/2007 |
Decision Date | 06/04/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|