OB-1 FETAL MONITOR


Device Classification Name

system, monitoring, perinatal

510(k) Number K011304
Device Name OB-1 FETAL MONITOR
Original Applicant
ANALOGIC CORP.
360 audubon rd.
wakefield, 
MA 
01880

Original Contact steven a clarke
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 04/30/2001
Decision Date 05/29/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Special
Reviewed by Third Party No

Combination Product

No