FETAL ASSIST


definition

Device Classification Name

system, monitoring, perinatal

510(k) Number K002548
Device Name FETAL ASSIST
Original Applicant
HUNTLEIGH DIAGNOSTICS LTD.
35 portmanmoor road
cardiff wales, 

GB

cf2 2hb

Original Contact b.j. colleypriest
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 08/17/2000
Decision Date 03/06/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Traditional
Reviewed by Third Party No

Combination Product

No