The following data is part of a premarket notification filed by Omron Electronics, Inc. with the FDA for Digital Blood Pressure Monitor Model Hem-703cp.
| Device ID | K882393 |
| 510k Number | K882393 |
| Device Name: | DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP |
| 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 | 1988-06-10 |
| Decision Date | 1988-08-30 |