The following data is part of a premarket notification filed by Omron Electronics, Inc. with the FDA for Omron Digital Blood Pressure Monitor Hem-401c.
| Device ID | K871207 |
| 510k Number | K871207 |
| Device Name: | OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON ELECTRONICS, INC. ONE EAST COMMERCE DR. Schaumburg, IL 60173 |
| Contact | Oishi |
| Correspondent | Oishi OMRON ELECTRONICS, INC. ONE EAST COMMERCE DR. Schaumburg, IL 60173 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-25 |
| Decision Date | 1987-05-28 |