The following data is part of a premarket notification filed by Xhale, Inc with the FDA for Nasal Alar Spo2 Sensor.
| Device ID | K171423 |
| 510k Number | K171423 |
| Device Name: | Nasal Alar SpO2 Sensor |
| Classification | Oximeter |
| Applicant | Xhale, Inc 3630 SW 47th Ave, Suite 100 Gainesville, FL 32608 |
| Contact | Jeffrey Hoebelheinrich |
| Correspondent | Paul Dryden Xhale, Inc. C/o ProMedic, LLC 24301 Woodsage Dr. Bonita Springs, FL 34134 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-15 |
| Decision Date | 2017-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838097593 | K171423 | 000 |
| 20884838097548 | K171423 | 000 |
| 20884838097173 | K171423 | 000 |