The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Colin Press Mate, Model Bp S510.
| Device ID | K063690 |
| 510k Number | K063690 |
| Device Name: | COLIN PRESS MATE, MODEL BP S510 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Contact | Ranndy Kellogg |
| Correspondent | Ranndy Kellogg OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Product Code | MHX |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-12 |
| Decision Date | 2007-05-09 |