SONICAID MODEL P110 FETAL HEAR DETECTOR

Monitor, Heart Rate, Fetal, Ultrasonic

OXFORD INSTRUMENTS, PLC.

The following data is part of a premarket notification filed by Oxford Instruments, Plc. with the FDA for Sonicaid Model P110 Fetal Hear Detector.

Pre-market Notification Details

Device IDK933816
510k NumberK933816
Device Name:SONICAID MODEL P110 FETAL HEAR DETECTOR
ClassificationMonitor, Heart Rate, Fetal, Ultrasonic
Applicant OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater,  FL  34620
ContactMichael J Smith
CorrespondentMichael J Smith
OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater,  FL  34620
Product CodeHEL  
CFR Regulation Number884.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-04
Decision Date1994-12-22

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