OMAR

Recorder, Magnetic Tape, Medical

OXFORD MEDILOG, INC.

The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Omar.

Pre-market Notification Details

• Device ID: K830915
• 510k Number: K830915
• Device Name: OMAR
• Classification: Recorder, Magnetic Tape, Medical
• Applicant: OXFORD MEDILOG, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DSH
• CFR Regulation Number: 870.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-03-22
• Decision Date: 1983-07-07