Cleared Traditional

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile

K221014 · Effortless Oxygen, LLC · Anesthesiology

Oct 2022

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K221014 is an FDA 510(k) clearance for the Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile, a Conserver, Oxygen (Class II — Special Controls, product code NFB), submitted by Effortless Oxygen, LLC (Phoenix, US). The FDA issued a Cleared decision on October 17, 2022, 195 days after receiving the submission on April 5, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K221014 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2022
Decision Date	October 17, 2022
Days to Decision	195 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF