The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Model Hbp-2070 Vital Signs Monitor.
| Device ID | K082812 |
| 510k Number | K082812 |
| Device Name: | OMRON MODEL HBP-2070 VITAL SIGNS MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| 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 | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2008-10-22 |
| Summary: | summary |