A SCOPE


Device Classification Name

stethoscope, electronic

510(k) Number K103499
Device Name A SCOPE
Applicant
ACTIVE SIGNAL TECHNOLOGIES, INC.
11874 south evelyn cir.
houston, 
TX 
77071

Applicant Contact harvey knauss
Correspondent
ACTIVE SIGNAL TECHNOLOGIES, INC.
11874 south evelyn cir.
houston, 
TX 
77071

Correspodent Contact harvey knauss
Regulation Number 870.1875
Classification Product Code
DQD  
Subsequent Product Code
JAF  
Date Received 11/29/2010
Decision Date 03/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No