FETALGARD LITE


the company

Device Classification Name

system, monitoring, perinatal

510(k) Number K002503
Device Name FETALGARD LITE
Original Applicant
ANALOGIC CORP.
8 centennial dr.
peabody, 
MA 
01960

Original Contact steven a clarke
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 08/14/2000
Decision Date 11/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Traditional
Reviewed by Third Party No

Combination Product

No