The following data is part of a premarket notification filed by Exalenz Bioscience Ltd. with the FDA for Breathid Smart System.
| Device ID | K193610 |
| 510k Number | K193610 |
| Device Name: | BreathID Smart System |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | Exalenz Bioscience Ltd. 4 Ha'Maayan St. Modiin, IL 7177872 |
| Contact | Raffi Werner |
| Correspondent | Raffi Werner Exalenz Bioscience 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 | 2019-12-26 |
| Decision Date | 2020-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016923223 | K193610 | 000 |
| 07290016923278 | K193610 | 000 |
| 07290016923353 | K193610 | 000 |
| 07290016923346 | K193610 | 000 |