The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Sonicaid Model Vasoflo 4.
| Device ID | K895909 |
| 510k Number | K895909 |
| Device Name: | SONICAID MODEL VASOFLO 4 |
| Classification | Monitor, Fetal Doppler Ultrasound |
| Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Contact | Michael J Smith |
| Correspondent | Michael J Smith OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
| Product Code | MAA |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-10 |
| Decision Date | 1990-07-09 |