The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Sonicaid Model Meridian 800.
Device ID | K902690 |
510k Number | K902690 |
Device Name: | SONICAID MODEL MERIDIAN 800 |
Classification | System, Monitoring, Perinatal |
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 | HGM |
CFR Regulation Number | 884.2740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-19 |
Decision Date | 1991-02-05 |