OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.

System, Measurement, Blood-pressure, Non-invasive

OMRON HEALTHCARE, INC.

The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Oscillometric Digital Blood Pressure Monit..

Pre-market Notification Details

• Device ID: K930798
• 510k Number: K930798
• Device Name: OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061
• Contact: Lee A Cabot
• Correspondent: Lee A Cabot; OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-02-16
• Decision Date: 1993-05-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00073796800369	K930798	000
00073796705367	K930798	000