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510(k) K130401

ALERTWATCH: OR by Alertwatch, LLC — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2014
Date Received
February 19, 2013
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 Alertwatch, LLC

  • K210160 — AlertWatch:AC (September 10, 2021)
  • K173715 — AlertWatch:OB (April 23, 2018)
  • K153335 — AlertWatch: OR (March 15, 2016)

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  • 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)