Home / 510(k) Clearances / K171311

510(k) K171311

A5 Anesthesia System by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2018
Date Received
May 2, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type

Other clearances by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

  • K253049 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, (February 11, 2026)
  • K251601 — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus (December 3, 2025)
  • K251853 — Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Conson (November 7, 2025)
  • K251820 — ViewMateTM Ultrasound System (September 12, 2025)
  • K251250 — ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound Syste (September 5, 2025)
  • K243767 — SV600, SV800 Ventilator (August 28, 2025)
  • K251192 — Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnos (August 22, 2025)
  • K242728 — BeneVision Central Monitoring System (July 31, 2025)
  • K250024 — TE Air Diagnostic Ultrasound System (May 30, 2025)
  • K250020 — Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9 (May 19, 2025)

Other clearances for product code BSZ

  • K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related (July 11, 2025)
  • K230931 — Atlan (July 23, 2023)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K201957 — A8, A9 Anesthesia System (March 26, 2021)
  • K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (March 18, 2020)
  • K171292 — A7 Anesthesia System (January 12, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia Sy (March 29, 2017)
  • K151570 — Carestation 620/650/650C (January 21, 2016)