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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Heart Rate, Fetal, Ultrasonic
510(k) Number K933816
Device Name SONICAID MODEL P110 FETAL HEAR DETECTOR
Applicant
OXFORD INSTRUMENTS, PLC.
11526 53RD ST. N.
CLEARWATER,  FL  34620
Applicant Contact MICHAEL J SMITH
Correspondent
OXFORD INSTRUMENTS, PLC.
11526 53RD ST. N.
CLEARWATER,  FL  34620
Correspondent Contact MICHAEL J SMITH
Regulation Number884.2660
Classification Product Code
HEL  
Date Received08/04/1993
Decision Date 12/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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