Omron Healthcare, Inc.
Omron Healthcare, Inc. appears in FDA public data with 0 recalls, 68 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 8, 2024.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 68
- Inspections
- 3
- Compliance Actions
- 0
Known Names
omron healthcare, omron healthcare co
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-A | October 8, 2024 |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | April 1, 2021 |
| K183215 | Focus TENS Therapy, Model PM710-M/-L | September 7, 2019 |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | April 17, 2019 |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | March 14, 2019 |
| K182120 | Maxpower Relief | January 10, 2019 |
| K181992 | Heat Pain Pro | November 9, 2018 |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | November 9, 2018 |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | November 8, 2018 |
| K182127 | Wrist Blood Pressure Monitor Model BP6100 | November 2, 2018 |
| K172079 | Avail | October 19, 2017 |
| K163235 | HEM-9210T | April 20, 2017 |
| K163045 | Omron HEM-6400T-Z Wrist Blood Pressure Monitor | February 21, 2017 |
| K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | November 22, 2016 |
| K160115 | Heat Pain Pro | June 3, 2016 |
| K141978 | MAXPOWER RELIEF | December 3, 2014 |
| K142917 | BP652N (HEM-6300-Z) | December 1, 2014 |
| K141140 | COMP A-I-R | September 30, 2014 |
| K133383 | HEM-7320 | March 4, 2014 |
| K133379 | HEM-7311 | January 16, 2014 |