VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)


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

Correspodent Contact tom j healy
Regulation Number 868.1840
Classification Product Code
BZG  
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