Oregon Scientific

System, Measurement, Blood-pressure, Non-invasive

IDT TECHNOLOGY LIMITED

The following data is part of a premarket notification filed by Idt Technology Limited with the FDA for Oregon Scientific.

Pre-market Notification Details

• Device ID: K151415
• 510k Number: K151415
• Device Name: Oregon Scientific
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: IDT TECHNOLOGY LIMITED BLOCK C, 9/F., KAISER ESTATE, PHASE 1, 41 MAN YUE STREET., HUNG HOM, KOWLOON Hong Kong, CN
• Contact: Lily Li
• Correspondent: Lily Li; IDT TECHNOLOGY LIMITED BLOCK C, 9/F., KAISER ESTATE, PHASE 1, 41 MAN YUE STREET., HUNG HOM, KOWLOON Hong Kong, CN
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-27
• Decision Date: 2015-10-21