OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M

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 Automatic Blood Pressure Monitor, Model Hem-780m.

Pre-market Notification Details

• Device ID: K042506
• 510k Number: K042506
• Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061
• Contact: Iwao Kojima
• Correspondent: Iwao Kojima; 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: 2004-09-15
• Decision Date: 2005-04-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00073796832223	K042506	000
00073796223144	K042506	000