The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Hem-6400t-z Wrist Blood Pressure Monitor.
| Device ID | K163045 |
| 510k Number | K163045 |
| Device Name: | Omron HEM-6400T-Z Wrist 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 224 Airport Parkway Suite 250 San Jose, CA 95110 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2017-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20073796260006 | K163045 | 000 |