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 |