Cleared Traditional

A8, A9 Anesthesia System

K201957 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Anesthesiology
Mar 2021
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K201957 is an FDA 510(k) clearance for the A8, A9 Anesthesia System, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 26, 2021, 255 days after receiving the submission on July 14, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K201957 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2020
Decision Date March 26, 2021
Days to Decision 255 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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