PACIFICA

Oximeter, Tissue Saturation

OR-NIM MEDICAL LTD.

The following data is part of a premarket notification filed by Or-nim Medical Ltd. with the FDA for Pacifica.

Pre-market Notification Details

• Device ID: K073407
• 510k Number: K073407
• Device Name: PACIFICA
• Classification: Oximeter, Tissue Saturation
• Applicant: OR-NIM MEDICAL LTD. 2001 PENNSYLVANIA AVE. NW SUITE 950 Washington, DC 20006
• Contact: Campbell Hutton
• Correspondent: Campbell Hutton; OR-NIM MEDICAL LTD. 2001 PENNSYLVANIA AVE. NW SUITE 950 Washington, DC 20006
• Product Code: MUD
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-12-04
• Decision Date: 2008-02-28
• Summary: summary