The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Model Sonicaid Axis.
Device ID | K912890 |
510k Number | K912890 |
Device Name: | MODEL SONICAID AXIS |
Classification | System, Monitoring, Perinatal |
Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
Contact | Charles Holz |
Correspondent | Charles Holz OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
Product Code | HGM |
CFR Regulation Number | 884.2740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-01 |
Decision Date | 1992-01-09 |