ELI 280 ELECTROCARDIOGRAPH


Device Classification Name

electrocardiograph

510(k) Number K122073
Device Name ELI 280 ELECTROCARDIOGRAPH
Applicant
MORTARA INSTRUMENT, INC.
7865 north 86th st.
milwaukee, 
WI 
53224

Applicant Contact amy yang
Correspondent
MORTARA INSTRUMENT, INC.
7865 north 86th st.
milwaukee, 
WI 
53224

Correspodent Contact amy yang
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 07/16/2012
Decision Date 08/02/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No