The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Intellisense Blood Pressure Monitor, Model Hem-907.
| Device ID | K001848 |
| 510k Number | K001848 |
| Device Name: | OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Osamu Shirasaki |
| Correspondent | Osamu Shirasaki OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-19 |
| Decision Date | 2000-07-03 |