The following data is part of a premarket notification filed by Exalenz Bioscience Ltd. with the FDA for Breathid Hp Lab System.
| Device ID | K173777 |
| 510k Number | K173777 |
| Device Name: | BreathID Hp Lab System |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | Exalenz Bioscience Ltd. 4 Ha'Maayan St. Modiin, IL 7177872 |
| Contact | Raffi Werner |
| Correspondent | George Hattub Medicsense USA 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-12-12 |
| Decision Date | 2018-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016923070 | K173777 | 000 |
| 20350402100148 | K173777 | 000 |
| 07290016923162 | K173777 | 000 |
| 07290016923391 | K173777 | 000 |
| 07290016923384 | K173777 | 000 |
| 07290016923063 | K173777 | 000 |