WATCHHALER— 510(k) K080100

Substantially Equivalent

Activaero America, Inc.

FDA 510(k) clearance K080100 for WATCHHALER, Substantially Equivalent on 2008-06-30. Applicant: Activaero America, Inc..

Clearance details

Applicant
Activaero America, Inc.
Product code
Code NVP
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bonita Springs, FL, US
Download summary PDFView on FDA.gov ↗

Adverse 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.