Exalenz Bioscience , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K193610 | BreathID Smart System | February 6, 2020 |
| K173772 | BreathID Hp System | March 8, 2018 |
| K173777 | BreathID Hp Lab System | March 8, 2018 |
| K162150 | BreathID Hp Lab System | October 31, 2016 |
| K130524 | BREATHID HP SYSTEM | May 22, 2013 |