The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Wrist Digital Blood Pressure Monitor Hem-601.
| Device ID | K920778 |
| 510k Number | K920778 |
| Device Name: | OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601 |
| 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 | 1992-02-20 |
| Decision Date | 1992-12-24 |