Cleared Traditional

SV600, SV800 Ventilator

K243767 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Anesthesiology

Aug 2025

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K243767 is an FDA 510(k) clearance for the SV600, 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 August 28, 2025, 265 days after receiving the submission on December 6, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K243767 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2024
Decision Date	August 28, 2025
Days to Decision	265 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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