SENSI


Device Classification Name

stethoscope, electronic

510(k) Number K110704
Device Name SENSI
Applicant
DIACOUSTIC MEDICAL DEVICES (PTY) LTD.
1468 harwell avenue
crofton, 
MD 
21114

Applicant Contact e.j. smith
Correspondent
DIACOUSTIC MEDICAL DEVICES (PTY) LTD.
1468 harwell avenue
crofton, 
MD 
21114

Correspodent Contact e.j. smith
Regulation Number 870.1875
Classification Product Code
DQD  
Date Received 03/14/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No