The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Automatic Blood Pressure Monitor With Intellisense, Models Hem-773, Hem-773ac.
| Device ID | K021682 |
| 510k Number | K021682 |
| Device Name: | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Iwao Kojima |
| Correspondent | Iwao Kojima 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 | 2002-05-22 |
| Decision Date | 2002-12-12 |