The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Medilog 9000-ii Ambulatory Recorder.
Device ID | K890647 |
510k Number | K890647 |
Device Name: | MEDILOG 9000-II AMBULATORY RECORDER |
Classification | Recorder, Magnetic Tape, Medical |
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 | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-10 |
Decision Date | 1989-03-15 |