The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Evolv Model Bp7000 Upper Arm Blood Pressure Monitor.
| Device ID | K162092 |
| 510k Number | K162092 |
| Device Name: | Evolv Model BP7000 Upper Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 1925 WEST FIELD COURT Lake Forest, IL 60045 |
| Contact | Renee Thornborough |
| Correspondent | Ronald S. Warren EXPERIEN GROUP 755 N. MATHILDA AVE, SUITE 100 Sunnyvale, CA 94085 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-28 |
| Decision Date | 2016-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10073796270008 | K162092 | 000 |