Cleared Traditional

Oxymag - Transport and Emergency Ventilator

K221634 · Magnamed Tecnologia Medica S/A · Anesthesiology

May 2023

Decision

352d

Days

Class 2

Risk

About This 510(k) Submission

K221634 is an FDA 510(k) clearance for the Oxymag - Transport and Emergency Ventilator, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Magnamed Tecnologia Medica S/A (Cotia, BR). The FDA issued a Cleared decision on May 24, 2023, 352 days after receiving the submission on June 6, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number	K221634 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2022
Decision Date	May 24, 2023
Days to Decision	352 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF