Smartinhaler
Nebulizer (direct Patient Interface)
Adherium (NZ) Ltd
The following data is part of a premarket notification filed by Adherium (nz) Ltd with the FDA for Smartinhaler.
Pre-market Notification Details
| Device ID | K180407 |
| 510k Number | K180407 |
| Device Name: | Smartinhaler |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland, NZ 1010 |
| Contact | Chris Mander |
| Correspondent | Chris Mander Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland, NZ 1010 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-14 |
| Decision Date | 2018-07-25 |
| Summary: | summary |
Trademark Results [Smartinhaler]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTINHALER 79182645 5343123 Live/Registered |
Adherium (NZ) Limited 2015-07-22 |
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