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510(k) K243767

SV600, SV800 Ventilator by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2025
Date Received
December 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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