Cleared Traditional

NASAL MASK, NASAL MASK, FULL FACE MASK

K133009 · BMC Medical Co., Ltd. · Anesthesiology

Apr 2014

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K133009 is an FDA 510(k) clearance for the NASAL MASK, NASAL MASK, FULL FACE MASK, 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 April 23, 2014, 210 days after receiving the submission on September 25, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K133009 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2013
Decision Date	April 23, 2014
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF