PORTABLE ECSCOPE 12I


Device Classification Name

electrocardiograph

510(k) Number K080036
Device Name PORTABLE ECSCOPE 12I
Applicant
DYANSYS, INC.
577 airport blvd. suite 610
burlingame, 
CA 
95032

Applicant Contact srini nageshwar
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 01/07/2008
Decision Date 01/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No