The following data is part of a premarket notification filed by Meridian Bioscience Israel Ltd. with the FDA for Breathid Hp Lab System, Breathid Smart System.
| Device ID | K220494 |
| 510k Number | K220494 |
| Device Name: | BreathID Hp Lab System, BreathID Smart System |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | Meridian Bioscience Israel Ltd. 4 Ha'Maayan St, Modiin, IL 7177872 |
| Contact | Raffi Werner |
| Correspondent | Raffi Werner Meridian Bioscience Israel Ltd. 4 Ha'Maayan St, Modiin, IL 7177872 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-06-23 |