The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Medilog 4500 System.
Device ID | K860079 |
510k Number | K860079 |
Device Name: | MEDILOG 4500 SYSTEM |
Classification | Detector And Alarm, Arrhythmia |
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 | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-08 |
Decision Date | 1986-02-26 |