DeviceClearance

AIM (N/A)— 510(k) K240937

Substantially Equivalent

Inventeur, LLC

FDA 510(k) clearance K240937 for AIM (N/A), Substantially Equivalent on 2024-12-16. Applicant: Inventeur, LLC. Device class: 2.

Clearance details

Applicant
Inventeur, LLC
Product code
Code CCK
Device class
Class 2
Regulation
21 CFR 868.1400
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lewes, DE, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CCK

view all

Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

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.