Cleared Traditional

Auto CPAP System

K211155 · BMC Medical Co., Ltd. · Anesthesiology

Mar 2022

Decision

324d

Days

Class 2

Risk

About This 510(k) Submission

K211155 is an FDA 510(k) clearance for the Auto CPAP System, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by BMC Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on March 9, 2022, 324 days after receiving the submission on April 19, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K211155 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2021
Decision Date	March 09, 2022
Days to Decision	324 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF