HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS


Device Classification Name

electrocardiograph

510(k) Number K022152
Device Name HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
Original Applicant
CAMBRIDGE HEART, INC.
20310 sw 48th st.
ft. lauderdale, 
FL 
33332

Original Contact john greenbaum
Regulation Number 870.2340
Classification Product Code
DPS  
Subsequent Product Code
DQK  
Date Received 07/02/2002
Decision Date 07/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No