The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Medilog Ph1.
Device ID | K840934 |
510k Number | K840934 |
Device Name: | MEDILOG PH1 |
Classification | Pill, Radio |
Applicant | OXFORD MEDILOG, INC. FL |
Product Code | EXW |
CFR Regulation Number | 876.1725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-05 |
Decision Date | 1984-06-28 |