The following data is part of a premarket notification filed by Oxford Instruments, Plc. with the FDA for Sonicaid Model P110 Fetal Hear Detector.
Device ID | K933816 |
510k Number | K933816 |
Device Name: | SONICAID MODEL P110 FETAL HEAR DETECTOR |
Classification | Monitor, Heart Rate, Fetal, Ultrasonic |
Applicant | OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater, FL 34620 |
Contact | Michael J Smith |
Correspondent | Michael J Smith OXFORD INSTRUMENTS, PLC. 11526 53RD ST. N. Clearwater, FL 34620 |
Product Code | HEL |
CFR Regulation Number | 884.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-04 |
Decision Date | 1994-12-22 |