The following data is part of a premarket notification filed by Exalenz Bioscience Ltd. with the FDA for Breathid Hp System.
| Device ID | K130524 |
| 510k Number | K130524 |
| Device Name: | BREATHID HP SYSTEM |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | EXALENZ BIOSCIENCE LTD. 11925 W I-70 FRONTAGE RD NORTH SUITE 900 Wheat Ridge, CO 80033 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo EXALENZ BIOSCIENCE LTD. 11925 W I-70 FRONTAGE RD NORTH SUITE 900 Wheat Ridge, CO 80033 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-02-28 |
| Decision Date | 2013-05-22 |
| Summary: | summary |