The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Auto. Oscillometric Digital Blood Press. Monitor.
| Device ID | K913523 |
| 510k Number | K913523 |
| Device Name: | AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Lee Cobot |
| Correspondent | Lee Cobot OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-08 |
| Decision Date | 1991-11-06 |