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510(k) K252589

Corvair Monza by AliveCor, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2026
Date Received
August 15, 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 AliveCor, Inc.

  • K232035 — Impala (June 7, 2024)
  • K231010 — Corvair (June 7, 2024)
  • K220350 — KardiaMobile 6L (May 25, 2022)
  • K212662 — AliveCor QT Service (April 26, 2022)
  • K211668 — KardiaMobile Card (November 30, 2021)
  • K210753 — KardiaMobile 6L (June 30, 2021)
  • K201985 — KardiaAI (November 12, 2020)
  • K191406 — KardiaMobile, KardiaStation (January 24, 2020)
  • K183319 — Triangle System (May 10, 2019)
  • K182396 — KardiaMobile, KardiaStation (April 12, 2019)

Other clearances for product code MHX

  • K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 (February 6, 2026)
  • K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); (December 17, 2025)
  • 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)