SONICAID ONE


Device Classification Name

system, monitoring, perinatal

510(k) Number K023618
Device Name SONICAID ONE
Original Applicant
OXFORD INSTRUMENTS MEDICAL LTD.
manor way
old woking, surrey, 

GB

gu22 9ju

Original Contact michael edwards
Regulation Number 884.2740
Classification Product Code
HGM  
Subsequent Product Code
HGL  
Date Received 10/29/2002
Decision Date 01/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No