Cleared Traditional

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

K241366 · Dehas Medical Systems GmbH · Anesthesiology

Oct 2024

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K241366 is an FDA 510(k) clearance for the QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV), a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Dehas Medical Systems GmbH (Luebeck, DE). The FDA issued a Cleared decision on October 29, 2024, 168 days after receiving the submission on May 14, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number	K241366 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2024
Decision Date	October 29, 2024
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF