The following data is part of a premarket notification filed by Exalenz Bioscience Ltd. with the FDA for Breathid Hp Lab System.
| Device ID | K162150 |
| 510k Number | K162150 |
| Device Name: | BreathID Hp Lab System |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | Exalenz Bioscience Ltd. 4 Ha'Maayan Street Modiin, IL 7177872 |
| Contact | Raffi Werner |
| Correspondent | Orna Oz Biomedical Strategy Ltd. 155 Bialik St. Ramat Gan, IL 5252346 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-08-02 |
| Decision Date | 2016-10-31 |
| Summary: | summary |