The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Hem-9000ai.
| Device ID | K081654 |
| 510k Number | K081654 |
| Device Name: | HEM-9000AI |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden OMRON HEALTHCARE, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-12 |
| Decision Date | 2008-10-10 |
| Summary: | summary |