The following data is part of a premarket notification filed by Omron Marshall Products, Inc. with the FDA for Omron Auto Oscillometric Dig Bp Mont/hem-704c 705c.
| Device ID | K903134 |
| 510k Number | K903134 |
| Device Name: | OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C |
| 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 | 1991-01-08 |