ACCU-TRAC

System, Measurement, Blood-pressure, Non-invasive

OLYMPIC MEDICAL CORP.

The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Accu-trac.

Pre-market Notification Details

• Device ID: K843055
• 510k Number: K843055
• Device Name: ACCU-TRAC
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: OLYMPIC MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-08-03
• Decision Date: 1985-05-28