The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Automatic Blood Pressure Monitor, Model Hem-711ac.
| Device ID | K052154 |
| 510k Number | K052154 |
| Device Name: | OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Contact | Iwao Kojima |
| Correspondent | Silvia Ankova UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-09 |
| Decision Date | 2005-09-08 |