MIDA ALGORITHM REV. B


Device Classification Name

vectorcardiograph

510(k) Number K023414
Device Name MIDA ALGORITHM REV. B
Original Applicant
ORTIVUS AB
enhagsslingan 5
taby, 

SE

se-18325

Original Contact kenneth eklund
Regulation Number 870.2400
Classification Product Code
DYC  
Date Received 10/11/2002
Decision Date 12/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No