WATCHHALER— 510(k) K080100
Substantially EquivalentActivaero America, Inc.
FDA 510(k) clearance K080100 for WATCHHALER, Substantially Equivalent on 2008-06-30. Applicant: Activaero America, Inc.. Device class: 2.
Clearance details
- Applicant
- Activaero America, Inc.
- Product code
- Code NVP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
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More clearances from Activaero America, Inc.
view allAdverse events under product code NVP
product code NVP- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.