The following data is part of a premarket notification filed by Airehealth Inc. with the FDA for Airehealth Nebulizertm.
| Device ID | K201167 |
| 510k Number | K201167 |
| Device Name: | AireHealth NebulizerTM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AireHealth Inc. 3251 Progess Dr., Suite F Orlando, FL 32826 |
| Contact | Rusty Kelly |
| Correspondent | Jessica Czamanski Regulatory And Quality Solutions, LLC 2790 Mosside Blvd #800 Monroeville, PA 15146 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002180618 | K201167 | 000 |