CARDIOSCOPE SONOPLUS 3000


Device Classification Name

electrocardiograph

510(k) Number K051126
Device Name CARDIOSCOPE SONOPLUS 3000
Applicant
PULSONIC AG, MEDICAL TECHNOLOGY
1308 morningside park drive
alpharetta, 
GA 
30022

Applicant Contact jay mansour
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 05/03/2005
Decision Date 05/19/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No