BIOLOGICAL SOUND MONITOR (BSM) SENSOR


Device Classification Name

stethoscope, electronic

510(k) Number K021389
Device Name BIOLOGICAL SOUND MONITOR (BSM) SENSOR
Original Applicant
ANDROMED, INC.
4610 chemin du bois-franc
saint laurent, quebec, 

CA

h4s 1a7

Original Contact genevieve hamel
Regulation Number 870.1875
Classification Product Code
DQD  
Date Received 05/02/2002
Decision Date 10/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No