The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Automatic Blood Pressure Monitor With Comfit Cuff, Model Hem 780 N3.
| Device ID | K061822 |
| 510k Number | K061822 |
| Device Name: | OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Contact | Donna Djinovich |
| Correspondent | Donna Djinovich 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-28 |
| Decision Date | 2006-08-02 |