Cleared Traditional

AIM (N/A)

K240937 · Inventeur, LLC · Anesthesiology

Dec 2024

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K240937 is an FDA 510(k) clearance for the AIM (N/A), a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Inventeur, LLC (Lewes, US). The FDA issued a Cleared decision on December 16, 2024, 255 days after receiving the submission on April 5, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K240937 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2024
Decision Date	December 16, 2024
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF