ISIS

Device, Sensing, Optical Contour

OXFORD MEDILOG, INC.

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

Pre-market Notification Details

• Device ID: K844736
• 510k Number: K844736
• Device Name: ISIS
• Classification: Device, Sensing, Optical Contour
• Applicant: OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520
• Contact: Jack M Frost
• Correspondent: Jack M Frost; OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520
• Product Code: LDK
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-12-05
• Decision Date: 1985-03-21