The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Intellisense Digital Blood Pressure Monitor, Model Hem-907xl.
| Device ID | K032305 |
| 510k Number | K032305 |
| Device Name: | OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL |
| 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 | 2003-07-25 |
| Decision Date | 2004-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00073796907426 | K032305 | 000 |
| 00073796907358 | K032305 | 000 |
| 00073796907341 | K032305 | 000 |
| 00073796907150 | K032305 | 000 |
| 00073796907037 | K032305 | 000 |
| 00073796907020 | K032305 | 000 |
| 00073796907013 | K032305 | 000 |
| 00073796149079 | K032305 | 000 |
| 00073796130428 | K032305 | 000 |