The following data is part of a premarket notification filed by Omron Healthcare, Inc with the FDA for Bp652n (hem-6300-z).
| Device ID | K142917 |
| 510k Number | K142917 |
| Device Name: | BP652N (HEM-6300-Z) |
| 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, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-07 |
| Decision Date | 2014-12-01 |
| Summary: | summary |