The following data is part of a premarket notification filed by Xhale, Inc. with the FDA for Assurance Alar / Nasal Spo2 Sensor.
| Device ID | K143216 |
| 510k Number | K143216 |
| Device Name: | Assurance Alar / Nasal SpO2 Sensor |
| Classification | Oximeter |
| Applicant | Xhale, Inc. 3630 SW 47th Ave, Suite 100 Gainesville, FL 32608 |
| Contact | Jeffrey Hoebelheinrich |
| Correspondent | Paul Dryden Xhale, Inc. 3630 SW 47th Ave, Suite 100 Gainesville, FL 32608 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-03-17 |
| Summary: | summary |