PORTABLE ECSCOPE


Device Classification Name

electrocardiograph

510(k) Number K072353
Device Name PORTABLE ECSCOPE
Applicant
DYANSYS CORP
577 airport blvd., suite 610
burlingame, 
CA 
95032

Applicant Contact srini nageshwar
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 08/22/2007
Decision Date 08/30/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No