510(k) K844007— PENLON PPV VAPORIZER

Substantially Equivalent

Penlon, Inc.

Clearance details

Applicant
Penlon, Inc.
Product code
Code CAD
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Riverside, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAD

product code CAD
Malfunction
3,275
Total
3,275

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.