OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C

System, Measurement, Blood-pressure, Non-invasive

OMRON MARSHALL PRODUCTS, INC.

The following data is part of a premarket notification filed by Omron Marshall Products, Inc. with the FDA for Omron Oscillometric Digital Bp Monitor-hem-405c.

Pre-market Notification Details

• Device ID: K903133
• 510k Number: K903133
• Device Name: OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: OMRON MARSHALL PRODUCTS, INC. 600 BARCLAY BLVD. Lincolnshire, IL 60069
• Contact: Casey Guzniczak
• Correspondent: Casey Guzniczak; OMRON MARSHALL PRODUCTS, INC. 600 BARCLAY BLVD. Lincolnshire, IL 60069
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-07-17
• Decision Date: 1991-01-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00073796043223	K903133	000
00073796014667	K903133	000