Cleared Traditional

Mindray SV600 Ventilator, Mindray SV800 Ventilator

K220107 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Anesthesiology

Jun 2023

Decision

520d

Days

Class 2

Risk

About This 510(k) Submission

K220107 is an FDA 510(k) clearance for the Mindray SV600 Ventilator, Mindray SV800 Ventilator, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 16, 2023, 520 days after receiving the submission on January 12, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K220107 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 2022
Decision Date	June 16, 2023
Days to Decision	520 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBK — Ventilator, Continuous, Facility Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5895

Manufacturer

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Shenzhen · CN

Yanhong Bai

154 submissions 154 cleared

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