The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Model Hbp T-105 Series, Model T-105 And T-105s.
| Device ID | K071645 |
| 510k Number | K071645 |
| Device Name: | MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden OMRON HEALTHCARE, INC. 3460 POINTE CREEK COURT #102 Bonita Springs, FL 34134 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-15 |
| Decision Date | 2007-07-02 |
| Summary: | summary |