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510(k) K240229

Masimo W1 by Masimo Corporation — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2024
Date Received
January 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Masimo Corporation

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  • K234021 — Masimo Stork (May 3, 2024)
  • K214115 — MightySat -OTC (January 31, 2024)
  • K223721 — Masimo Stork (December 15, 2023)
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  • DEN200076 — ORi (October 12, 2023)
  • K232389 — Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (September 7, 2023)
  • K223498 — Radius VSM and Accessories (June 1, 2023)

Other clearances for product code DPS

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
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  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K250569 — Cardiologs Holter Platform (August 6, 2025)
  • K243252 — ZBPro Diagnostic (July 10, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)
  • K233266 — MEDIBLU ECG SYSTEM (June 12, 2024)