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510(k) K252182

SV70 Ventilator (SV70) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code MNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2026
Date Received
July 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sv70 Ventilator
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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  • K230173 — Servo-air Lite Ventilator System (July 6, 2023)
  • K213521 — Nihon Kohden NKV-330 Ventilator System (July 1, 2022)
  • K191624 — F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Versio (March 9, 2020)
  • K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large (August 24, 2017)
  • K122715 — STELLAR 150 (June 17, 2013)
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