The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Ambulatory Monitoring Device.
Device ID | K833162 |
510k Number | K833162 |
Device Name: | AMBULATORY MONITORING DEVICE |
Classification | Detector And Alarm, Arrhythmia |
Applicant | OXFORD MEDILOG, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-16 |
Decision Date | 1984-01-10 |