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510(k) K250854

Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) by Shenzhen Comen Medical Instruments Co.,Ltd — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2025
Date Received
March 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Shenzhen Comen Medical Instruments Co.,Ltd

  • K250190 — Sequential Compression System (SCD600) (December 8, 2025)
  • K211619 — Multi-Parameter Patient Monitor (December 29, 2022)
  • K191106 — C50 and C80 Multi-parameter Patient Monitor (December 13, 2019)
  • K173454 — Multi-parameter Patient Monitor, models C30 (August 16, 2018)

Other clearances for product code MHX

  • K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 (February 6, 2026)
  • K252589 — Corvair Monza (January 9, 2026)
  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)
  • K240312 — Infinity CentralStation Wide (August 1, 2024)