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510(k) K241890

Philips Holter Analysis System by Philips Medizin Systeme Böblingen GmbH — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2025
Date Received
June 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Philips Medizin Systeme Böblingen GmbH

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  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)
  • K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 98980 (January 17, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K221348 — IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (8664 (February 3, 2023)
  • K211900 — Patient Information Center iX (March 4, 2022)

Other clearances for product code MLO

  • K240794 — Frontier X Plus (November 8, 2024)
  • K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System (September 2, 2020)
  • K193177 — CER-S (August 26, 2020)
  • K182030 — Faros Mobile (November 8, 2018)
  • K140847 — CARDIOSPY ECG HOLTER SYSTEMS (December 5, 2014)
  • K131897 — CV3000 HOLTER ANALYSIS SYSTEM (November 26, 2013)
  • K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR) (October 11, 2013)
  • K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED (September 20, 2012)
  • K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (November 10, 2011)
  • K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (October 24, 2011)