EASI ECG ALGORITHM

Device Classification Name

adaptor, lead switching, electrocardiograph

510(k) Number K033513
Device Name EASI ECG ALGORITHM
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Applicant Contact david osborn
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Correspodent Contact david osborn
Regulation Number 870.2350
Classification Product Code
DRW  
Date Received 11/06/2003
Decision Date 01/15/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No