VITALOGRAPH MODEL 7100 – VITALOJAK


Device Classification Name

recorder, magnetic tape, medical

510(k) Number K110525
Device Name VITALOGRAPH MODEL 7100 – VITALOJAK
Applicant
VITALOGRAPH(IRELAND) LTD.
ennis industrial estate
gort road business park
ennis, co. clare, 

IE

ei

Applicant Contact tom j healy
Correspondent
VITALOGRAPH(IRELAND) LTD.
ennis industrial estate
gort road business park
ennis, co. clare, 

IE

ei

Correspodent Contact tom j healy
Regulation Number 870.2800
Classification Product Code
DSH  
Date Received 02/23/2011
Decision Date 11/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No