BT-350


Device Classification Name

system, monitoring, perinatal

510(k) Number K103545
Device Name BT-350
Applicant
BISTOS CO., LTD.
4802 glenwood road
brooklyn, 
NY 
11234

Applicant Contact steve kohn
Correspondent
BISTOS CO., LTD.
4802 glenwood road
brooklyn, 
NY 
11234

Correspodent Contact steve kohn
Regulation Number 884.2740
Classification Product Code
HGM  
Subsequent Product Code
HGL  
Date Received 12/02/2010
Decision Date 05/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No