The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Model Bp7900 Blood Pressure Monitor + Ekg.
| Device ID | K182579 |
| 510k Number | K182579 |
| Device Name: | Omron Model BP7900 Blood Pressure Monitor + EKG |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Omron Healthcare, Inc. 1925 West Field Court, Suite 100 Lake Forest, IL 60045 |
| Contact | Renee Thornborough |
| Correspondent | Ronald S. Warren Experien Group 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
| Product Code | DXN |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-19 |
| Decision Date | 2019-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10073796267909 | K182579 | 000 |
| 10073796343924 | K182579 | 000 |
| 10073796341722 | K182579 | 000 |