The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Non-invasive Blood Pressure Monitor With Augmentation Index, Model Hem-9000ai.
| Device ID | K050233 |
| 510k Number | K050233 |
| Device Name: | OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Contact | Jim Li, Ph.d. |
| Correspondent | Jim Li, Ph.d. OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 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 | 2005-02-01 |
| Decision Date | 2005-10-28 |
| Summary: | summary |