The following data is part of a premarket notification filed by Thayer Medical Corporation with the FDA for Liteaire Basic Dual-valved, Collapsible Mdi Holding Chamber.
| Device ID | K210558 |
| 510k Number | K210558 |
| Device Name: | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | Thayer Medical Corporation 4575 S. Palo Verde Road, Suite 337 Tucson, AZ 85714 |
| Contact | Christine Woeppel |
| Correspondent | Christine Woeppel Thayer Medical Corporation 4575 S. Palo Verde Road, Suite 337 Tucson, AZ 85714 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2022-04-01 |