Cleared Traditional

BPAP System

K213169 · BMC Medical Co., Ltd. · Anesthesiology
Dec 2022
Decision
433d
Days
Class 2
Risk

About This 510(k) Submission

K213169 is an FDA 510(k) clearance for the BPAP System, a Ventilator, Continuous, Non-life-supporting (Class II — Special Controls, product code MNS), submitted by BMC Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 5, 2022, 433 days after receiving the submission on September 28, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K213169 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2021
Decision Date December 05, 2022
Days to Decision 433 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNS — Ventilator, Continuous, Non-life-supporting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895