The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Hem-9210t.
| Device ID | K163235 |
| 510k Number | K163235 |
| Device Name: | HEM-9210T |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045 |
| Contact | Renee Thornborough |
| Correspondent | Paul Dryden ProMedic, LLC 24301 Woodsage Dr. Bonita Springs, FL 34134 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-17 |
| Decision Date | 2017-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10073796921009 | K163235 | 000 |
| 00073796842314 | K163235 | 000 |
| 10073796893108 | K163235 | 000 |
| 10073796423121 | K163235 | 000 |