WATCHHALER
Holding Chambers, Direct Patient Interface
ACTIVAERO AMERICA, INC.
The following data is part of a premarket notification filed by Activaero America, Inc. with the FDA for Watchhaler.
Pre-market Notification Details
| Device ID | K080100 |
| 510k Number | K080100 |
| Device Name: | WATCHHALER |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | ACTIVAERO AMERICA, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ACTIVAERO AMERICA, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-06-30 |
| Summary: | summary |
Trademark Results [WATCHHALER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WATCHHALER 76372224 2717204 Dead/Cancelled |
ACTIVAERO GMBH 2002-02-19 |
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