The following data is part of a premarket notification filed by Oxford Instruments, Plc. with the FDA for Sonicaid Model Team Fecg Iup.
Device ID | K930714 |
510k Number | K930714 |
Device Name: | SONICAID MODEL TEAM FECG IUP |
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 | 1993-02-11 |
Decision Date | 1995-08-24 |