The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Model Medilog Rapide.
Device ID | K923737 |
510k Number | K923737 |
Device Name: | MODEL MEDILOG RAPIDE |
Classification | Monitor, Breathing Frequency |
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 | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-27 |
Decision Date | 1994-01-05 |