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 |