DeviceClearance

ENERGETIC HI-HUM AERSOL UNIT— 510(k) K831162

Substantially Equivalent

Energetic Pulmonary

FDA 510(k) clearance K831162 for ENERGETIC HI-HUM AERSOL UNIT, Substantially Equivalent on 1983-05-09. Applicant: Energetic Pulmonary. Device class: 2.

Clearance details

Applicant
Energetic Pulmonary
Product code
Code CAF
Device class
Class 2
Regulation
21 CFR 868.5630
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CAF

view all

Adverse events under product code CAF

product code CAF
Death
22
Injury
125
Malfunction
613
Other
11
Total
771

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.